(a) Basis. This subpart implements the test of the Ambulatory Specialty Model (ASM) under section 1115A of the Act.

(b) Scope. This subpart sets forth the following:

(1) The method for selecting ASM participants.

(2) The methodology for ASM participant performance assessment and scoring for purposes of the improvement activities ASM performance category, quality ASM performance category, cost ASM performance category, and Promoting Interoperability ASM performance category, including beneficiary inclusion and episode-based cost measures.

(3) Data submission for applicable ASM performance categories.

(4) The schedule and methodologies for payment adjustments.

(5) Appeals process.

(6) Data sharing with ASM participants.

(7) ASM beneficiary incentives.

(8) Collaborative care arrangements.

(9) Application of the CMS-sponsored model arrangements and patient incentives safe harbor.

(10) Medicare program waivers.

(11) Except as specifically noted in this subpart, the regulations under this subpart do not affect the applicability of other provisions affecting providers and suppliers under Medicare fee for service, including the applicability of provisions regarding payment, coverage, or program integrity.

(c) Applicability. Except as otherwise specified in this subpart, ASM participants are subject to the standard provisions for Innovation Center models specified in subpart A of this part 512 and in subpart K of part 403 of this chapter.

For purposes of this part, the terms in this part have the same meanings as 42 CFR 512.110 and 414.1300 unless otherwise stated.

ASM beneficiary means a Medicare FFS beneficiary who is being treated by an ASM participant for a targeted chronic condition.

ASM cohort means a group of ASM participants who treat the same ASM targeted chronic condition, specifically the ASM heart failure cohort and the ASM back pain cohort.

ASM data sharing agreement means an agreement between the ASM participant, and CMS that includes the terms and conditions for any beneficiary-identifiable data being shared with the ASM participant under § 512.760(e).

ASM heart failure cohort refers to all ASM heart failure participants.

ASM heart failure participant means an ASM participant who meets the ASM participant eligibility criteria related to heart failure.

ASM incentive pool means a fixed percentage of the total amount of Medicare Part B covered professional services claims paid to ASM participants with final scores within an ASM cohort during an ASM performance year that would be distributed in the form of scaled payment adjustments during an ASM payment year. CMS calculates an ASM incentive pool for each ASM cohort for each ASM payment year as described at § 512.750(c)(1)(iii).

ASM low back pain cohort refers to all ASM low back pain participants.

ASM low back pain participant means an ASM participant who meets the ASM participant eligibility criteria related to low back pain.

ASM participant means an individual clinician who, for at least one ASM performance year, satisfies the ASM participant eligibility criteria and has been selected for participation in the model as described at § 512.710(g).

ASM participant eligibility criteria means the set of criteria defined at § 512.710(b) that CMS uses to determine whether a clinician is selected to participate in ASM.

ASM payment adjustment factor means a percent value based on an ASM participant's final score as described at § 512.750(c)(1) that CMS uses in calculating adjustments to the ASM participant's Medicare Part B payments for covered professional services during an ASM payment year.

ASM payment multiplier means the numerical value equal to 1 plus the ASM payment adjustment factor determined for an ASM participant for an applicable ASM payment year as described at § 512.750(c).

ASM payment year means a calendar year in which CMS applies the ASM payment multiplier to Medicare Part B payments based on the final score achieved by that ASM participant for the ASM performance year 2 years prior.

ASM performance category means a group of applicable measures or activities used to assess ASM participant's performance on quality, cost, improvement activities, or Promoting Interoperability.

ASM performance category score means the assessment of each ASM participant's performance on the applicable measures and activities for a performance category during an ASM performance year based on the performance standards described at §§ 512.715, 512.725, 512.730, 512.735, and 512.740.

ASM performance report means the notification that CMS provides to the ASM participant for each ASM performance year, which contains the information specified at § 512.745(b).

ASM performance year means a 12-month period beginning on January 1 and ending on December 31 of each year during the first 5 calendar years of ASM test period.

ASM redistribution percentage means a percentage of Medicare Part B covered professional services payments to ASM participants during an ASM performance year that CMS distributes in the form of payment adjustment to ASM participants during an ASM payment year as described at § 512.750(c)(1)(iii).

ASM risk level means the magnitude of the maximum positive or negative net payment adjustment percentage to which an ASM participant would be subject to during an ASM payment year as described at § 512.750(c)(1)(i).

ASM targeted chronic condition means a medical condition that is a core focus of ASM; that is, heart failure or low back pain.

ASM test period means the 7-year period from January 1, 2027, to December 31, 2033, that includes all ASM performance years and ASM payment years.

ASTP/ONC stands for the Assistant Secretary for Technology Policy/Office of the National Coordinator on Health Information Technology.

CY means calendar year.

CEHRT stands for Certified Electronic Health Records Technology that meets the requirements set forth in § 414.1305 of this chapter, except all instances of references to Merit-based Incentive Payment System (MIPS) are to be replaced with references to ASM.

Clinician has the same meaning as “eligible professional” as defined in section 1848(k)(3) of the Act, as identified by a unique TIN and NPI combination.

CMS EHR Certification ID means the identification number that represents the combination of Certified Health Information Technology that is owned and used by providers and hospitals to provide care to their patients and is generated by the Certified Health IT Product List.

Collaborative care arrangement means an arrangement that meets all of the requirements set forth in § 512.771.

Core Based Statistical Area (CBSA) means a statistical geographic area, based on the definition as identified by the Office of Management and Budget in the OMB Bulletin 23-01 issued on July 21, 2023, with a population of at least 10,000, which consists of a county or counties anchored by at least one core (urbanized area or urban cluster), plus adjacent counties having a high degree of social and economic integration with the core (as measured through commuting ties with the counties containing the core).

Covered entity has the meaning set forth at 45 CFR 160.103.

Covered professional services means “covered services” and has the meaning set forth in § 512.110 of this chapter.

CQM stands for Clinical Quality Measures.

Days means calendar days unless otherwise specified by CMS.

Dual eligible proportion means the share of a participant's beneficiaries who are dually eligible Medicare beneficiaries

Dually eligible Medicare beneficiary means a beneficiary enrolled in both Medicare and full Medicaid benefits.

EBCM stands for episode-based cost measure and means the standardized Medicare-allowed cost for the items and services furnished to a patient during an episode of care, based on FFS claims and Medicare Part D claims data.

eCQM stands for electronic clinical quality measures.

EHR stands for Electronic Health Record and means a “Base EHR,” as defined at 45 CFR 170.102.

Exchange function means the function used to translate an ASM participant's final score into an ASM payment adjustment factor as described at § 512.750(c)(1)(ii)..

Episode means all the relevant health care services a patient receives during a specified period for the treatment of a physical or behavioral health condition.

FFS stands for fee-for-service.

Final score means a composite assessment (using a scoring scale of zero to 100) for each ASM participant for an ASM performance year determined using the methodology for assessing the total performance of an ASM participant according to performance standards for applicable measures and activities for each ASM performance category as described in § 512.745.

HCC risk score stands for Hierarchical Condition Category risk score and means the risk score assigned to a Medicare beneficiary in accordance with the HCC risk adjustment model established by CMS under section 1853(a)(1) of the Act.

Health-related social need means an unmet, adverse social condition that can contribute to poor health outcomes and is a result of underlying social determinants of health, which refer to the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.

Improvement activities mean activities relating to care coordination, integration of specialty and primary care, and addressing health-related social needs of patients.

Mandatory geographic area means a CBSA or metropolitan division as defined by the Office of Management and Budget and selected by CMS under the terms of § 512.710(f).

Meaningful EHR user means an ASM participant who possesses CEHRT, uses the functionality of CEHRT, reports on applicable objectives and measures specified for the Promoting Interoperability ASM performance category for a performance period in the form and manner specified by CMS, does not knowingly and willfully take action (such as to disable functionality) to limit or restrict the compatibility or interoperability of CEHRT, and engages in activities related to supporting providers with the performance of CEHRT.

Measure achievement points mean numerical values assigned to an ASM participant's reported performance data, that CMS uses to calculate an ASM performance category score.

Metropolitan division means—(1) A county or group of counties (or equivalent entities) delineated within a larger metropolitan statistical area, provided that the larger metropolitan statistical area contains a single core with a population of at least 2.5 million and other criteria are met; and

(2) Consists of one or more main or secondary counties that represent an employment center or centers, plus adjacent counties associated with the main/secondary county or counties through commuting ties.

Metropolitan statistical area means the county or counties (or equivalent entities) associated with at least one urban area of at least 50,000 population, plus adjacent counties having a high degree of social and economic integration with the core as measured through commuting ties.

MIPS stands for the Merit-based Incentive Payment System.

NPI stands for National Provider Identifier.

ONC-ACB stands for ONC-Authorized Certification Bodies.

Physician has the meaning set forth in section 1861(r) of the Act.

Primary care services has the meaning set forth in section 1842(i)(4) of the Act.

Risk indicator refers to hierarchical condition category (HCC) risk scores under the HCC risk adjustment model established by CMS under section 1853(a)(1) of the Act or the proportion of beneficiaries with dual eligible status used in calculating the complex patient scoring adjustment as defined at § 512.745(a)(3).

SAFER stands for Safety Assurance Factors for EHR Resilience.

Scaling factor means a numerical value calculated by CMS to ensure that the total estimated payment adjustments in an ASM payment year are equal to the ASM incentive pool for the applicable ASM payment year as described at § 512.750(c)(1)(iv).

Small practice means a practice consisting of 15 or fewer clinicians at the time we identify ASM participants for an ASM performance year as described at § 512.710(g).

Specialty type means a medical specialty as determined by the specialty code indicated on the plurality of a clinician's Medicare Part B claims.

Solo practitioner means a practice consisting of 1 clinician at the time we identify ASM participants for an ASM performance year as described at § 512.710(g).

Submission type means the mechanism by which the ASM submitter submits data to CMS in the form and manner specified by CMS, including, but not limited to all of the following:

(1) Direct.

(2) Log in and upload.

(3) Log in and attest.

Third -party intermediary has the meaning set forth in § 414.1305 of this chapter.

TIN stands for Taxpayer Identification Number.

Topped out measure has the meaning of either topped out process measure or topped out non-process measure set forth in § 414.1305 of this chapter.

U.S. Territories has the meaning set forth in § 512.110 of this chapter.

(a) Mandatory ASM participation. (1) Unless otherwise specified, any clinician who meets all ASM participant eligibility criteria as specified in paragraph (b) of this section and furnishes covered services during any applicable ASM performance year within the ASM test period is considered an ASM participant for the duration of the model.

(i) 2027 ASM performance year: ASM participants—

(A) Are measured for performance and exempted from MIPS participation, if applicable, during CY 2027;

(B) Report and are scored during CY 2028; and

(C) Receive payment adjustments for CY 2027 performance in CY 2029.

(ii) 2028 ASM performance year: ASM participants—

(A) Meeting ASM eligibility criteria for the 2028 performance year are measured for performance and exempted from MIPS participation, if applicable, during CY 2028;

(B) Report and are scored during CY 2029; and

(C) Receive payment adjustments for CY 2028 performance in CY 2030.

(iii) 2029 ASM performance year: ASM participants—

(A) Meeting ASM eligibility criteria for the 2029 performance year are measured for performance and exempted from MIPS participation, if applicable, during CY 2029;

(B) Report and are scored during CY 2030; and

(C) Receive payment adjustments for CY 2029 performance in CY 2031.

(iv) 2030 ASM performance year: ASM participants—

(A) Meeting ASM eligibility criteria for the 2030 performance year are measured for performance and exempted from MIPS participation, if applicable, during CY 2030;

(B) Report and are scored during CY 2031; and

(C) Receive payment adjustments for CY 2030 performance in CY 2032.

(v) 2031 ASM performance year: ASM participants—

(A) Meeting ASM eligibility criteria for the 2031 performance year are measured for performance and exempted from MIPS participation, if applicable, during CY 2031;

(B) Report and are scored during CY 2032; and

(C) Receive payment adjustments for CY 2031 performance in CY 2033.

(2)(i) For any ASM performance year within the ASM test period that an ASM participant does not meet the criteria for mandatory participation set forth in this section, the ASM participant is not subject, for the applicable ASM performance year, to §§ 512.715, 512.720, 512.745, and 512.750.

(ii) For a ASM performance year described in paragraph (a)(2)(i) of this section, the ASM participant is no longer eligible for the waivers as described at § 512.775 and is instead subject to MIPS reporting obligations, if applicable.

(b) ASM participant eligibility criteria. CMS uses the following set of criteria to determine whether a clinician is an ASM participant:

(1) Is a clinician who bills claims under the Medicare Physician Fee Schedule.

(2) Is identified by TIN/NPI as a selected specialty type as described in paragraph (d) of this section.

(3) Meets the EBCM episode volume threshold applicable to an ASM targeted chronic condition as described at paragraph (e) of this section.

(4) Is located in one of the mandatory geographic areas selected in accordance with paragraph (f) of this section.

(c) Participant exclusion due to change in TIN during an ASM performance year. (1) An ASM participant who stops assigning billing rights to the TIN used to identify the ASM participant and begins assigning billing rights to a new TIN during an applicable ASM performance year must notify CMS of the change in a form and manner determined by CMS within 30 days of the change.

(2)(i) An ASM participant who notifies CMS of a change in TIN during an ASM performance year is not subject, for the applicable ASM performance year, to §§ 512.715, 512.720, 512.745, and 512.750.

(ii) The ASM participant described in paragraph (c)(2)(i) of this section is no longer eligible for the waivers as described at § 512.775 and is instead subject to MIPS reporting obligations, if applicable.

(d) Specialty type. ASM participants have one of the following Medicare Part B specialty codes indicated on the plurality of their Medicare Part B claims:

(1) Heart failure specialty type 3/4

(i) Cardiology.

(ii) [Reserved]

(2) Low back pain specialty type 3/4

(i) Anesthesiology.

(ii) Interventional Pain Management.

(iii) Neurosurgery.

(iv) Orthopedic Surgery.

(v) Pain Management.

(vi) Physical Medicine and Rehabilitation.

(e) EBCM episode volume. To determine if a clinician meets the ASM participant eligibility criterion defined in paragraph (b)(3) of this section, CMS uses the volume of EBCM episodes related to ASM targeted chronic conditions that are attributed to a clinician using the applicable EBCM specifications and attribution methodology.

(1) Heart failure EBCM. Clinicians who have a specialty designation type described at § 512.710(d)(1) and 20 or more heart failure EBCM episodes attributed in accordance with the heart failure episode-based cost measure as specified under MIPS during the calendar year 2 years prior to the applicable ASM performance year meet the ASM participant eligibility criterion defined in paragraph (b)(3) of this section.

(2) Low back pain EBCM. Clinicians who have a specialty designation type described at § 512.710(d)(2) and 20 or more low back pain EBCM episodes attributed in accordance with the low back pain episode-based cost measure as specified under MIPS during the calendar year 2 years prior to the applicable ASM performance year meet the ASM participant eligibility criterion defined in paragraph (b)(3) of this section.

(f) Mandatory geographic areas. CMS uses a stratified random sampling methodology described in paragraphs (f)(2) and (f)(3) of this section to select CBSA and metropolitan divisions (in cases where OMB divides large metropolitan statistical areas into metropolitan divisions) from which CMS identifies clinicians for participation in ASM.

(1) Exclusions. CMS excludes from the selection of CBSAs and metropolitan divisions applicable areas that meet any of criteria described in paragraph (f)(1)(i) or (f)(2)(ii) of this section.

(i) Areas that do not meet the criteria described in paragraphs (f)(1)(i)(A) and (f)(1)(i)(B) of this section:

(A) Have at least one clinician with a specialty designation type described at § 512.710(d)(1) with 20 or more heart failure EBCM episodes attributed between January 1, 2024 and December 31, 2024.

(B) Have at least one clinician with a specialty designation type described at § 512.710(d)(2) with 20 or more low back pain EBCM episodes attributed between January 1, 2024 and December 31, 2024.

(ii) Areas located entirely in U.S. Territories.

(2) CBSA and metropolitan division stratification process. Prior to sampling CBSAs and metropolitan divisions, CMS stratifies CBSAs and metropolitan divisions, excluding those described in paragraph (f)(1) of this section, into six mutually exclusive strata based on three CBSA/metropolitan division-level characteristics (average total Part A and Part B episode spending, volume of eligible episodes, and metropolitan division status) as described in paragraphs (f)(2)(i) through (vi) of this section. “Average total episode spending” as the term is used in paragraphs (f)(2)(i) through (vi) of this section, is measured using the average total Part A and Part B episode spending using claims data from January 1, 2024 to December 31, 2024 relating to heart failure and low back pain episodes, as specified under the episode-based cost measures described in § 512.710(e). Values below the median are characterized as “Low” average total episode spending. Values at or above the median are characterized as “High” average total spending. “Eligible episode volume” as the term is used in paragraphs (f)(2)(i) through (vi) of this section, is measured as the total count of eligible heart failure and low back pain episodes, as specified under the episode-based cost measures described in § 512.710(e), in a CBSA between January 1, 2024 and December 31, 2024. CMS categorizes CBSAs with values below the median as “Low;” CBSAs at-or-above the median and below the 95th percentile as “High;” and CBSAs at-or-above the 95th percentile as “Very High.”.

(i) CBSAs with “Low” average total episode spending and “Low” eligible episode volume.

(ii) CBSAs with “Low” average total episode spending and “High” eligible episode volume.

(iii) CBSAs with “High” average total episode spending (as defined below) and “Low” eligible episode volume.

(iv) Eligible CBSAs with “High” average total episode spending and “High” eligible episode volume.

(v) Eligible CBSAs with “Very High” eligible episode volume.

(vi) Eligible metropolitan divisions.

(3) Sampling of CBSAs and metropolitan divisions. CMS selects approximately 40 percent of CBSAs and metropolitan divisions from each stratum to select the mandatory geographic areas. If 40 percent of a given stratum does not result in a whole number of CBSAs or metropolitan divisions, CMS rounds up to the next whole number to ensure that at least 40 percent of areas from each stratum are selected.

(4) Assignment of CBSA or metropolitan division code to clinicians. CMS assigns a CBSA or a metropolitan division code to every TIN/NPI with attributed EBCM episodes related to ASM targeted chronic conditions for the applicable calendar year as described in paragraph (e) of this section to determine ASM participation eligibility for an applicable ASM performance year:

(i) CMS assigns each attributed EBCM episode a ZIP Code, which represents the service location where the attributed TIN/NPI encounters the beneficiary attributed to the episode the most, based on the plurality of Part B claims used to construct the episode. If the ZIP Codes representing service location where the attributed TIN/NPI appears in equal number in the Part B claims used to construct the episode, then CMS assigns the ZIP Code based on the ZIP Code that represents the Part B claim with—

(A) The highest total cost indicated by the total standardized allowed amount; or

(B) Most recent date.

(ii) CMS assigns each attributed EBCM episode a CBSA or metropolitan division code based on the ZIP Code assigned to the episode as described in paragraph (f)(4)(i) of this section. If the ZIP Code assigned to the EBCM episode is in multiple CBSAs or metropolitan divisions, then CMS assigns the EBCM episode the CBSA or metropolitan division code where the ZIP Code has the highest proportion of—

(A) Total addresses; or

(B) Business addresses.

(iii) CMS assigns each TIN/NPI combination a single CBSA or metropolitan division code based on the most common CBSA or metropolitan division code assigned to episodes attributed to the TIN/NPI as described in paragraph (f)(4)(ii) of this section. If the TIN/NPI has equal number of episodes across multiple CBSAs or metropolitan divisions, then CMS assigns the TIN/NPI a CBSA or metropolitan division with the CBSA or metropolitan division that has either of the following:

(A) The highest total risk-adjusted episode spending across all episodes assigned to the CBSA or metropolitan division.

(B) Episodes with more recent dates.

(g) Selection and notification process for ASM participants. For each ASM performance year, CMS identifies all clinicians furnishing covered services using the ASM participant eligibility criteria specified in paragraph (b) of this section and applicable data from 2 calendar years prior to each ASM performance year. Any clinician selected for participation for any year of the model is considered an ASM participant for the remainder of the ASM test period.

(1) 2027 ASM performance year only—(i) Preliminarily eligible ASM participants. Using applicable data from calendar year 2024, CMS identifies all clinicians who meet the ASM participant eligibility criteria for participation starting in the 2027 ASM performance year/2029 ASM payment year. The clinicians identified as preliminarily eligible ASM participants are made public in a form and manner determined by CMS.

(ii) Final ASM participants. CMS identifies the final ASM participants selected for participation starting in the 2027 ASM performance year/2029 ASM payment year by confirming that the preliminarily eligible ASM participants identified under paragraph (g)(1)(i) of this section meet the ASM participant eligibility criteria using applicable data from CY 2025. The clinicians selected as ASM participants starting the 2027 ASM performance year/2029 ASM payment year is made public in a form and manner determined by CMS.

(2) 2028 ASM performance year and subsequent years. (i) Beginning with the 2028 ASM performance year/2030 ASM payment year, CMS determines if the previously selected ASM participants continue to meet the ASM participant eligibility criteria for the upcoming ASM performance year/ASM payment year using applicable data from the calendar year 2 years prior to the applicable ASM performance year. An ASM participant who does not meet the ASM participant eligibility criteria for the upcoming ASM performance year/ASM payment year is not subject to provisions described at §§ 512.715, 512.720, and 512.745 and must, if applicable, participate in MIPS. The final ASM participants selected for participation for each applicable ASM performance year is made public in a form and manner determined by CMS.

(ii) Beginning with the 2028 ASM performance year/2030 ASM payment year and prior to the start of each ASM performance year, CMS determines if additional clinicians not previously identified as ASM participants meet the ASM participant eligibility criteria for the upcoming ASM performance year/ASM payment year using applicable data from the calendar year 2 years prior to the applicable ASM performance year. The final ASM participants selected for participation for each applicable ASM performance year is made public in a form and manner determined by CMS.

(a) General. As further described in §§ 512.725, 512.730, 512.735, and 512.740:

(1) An ASM participant receives a specific number of points for its performance on each measure or activity within an ASM performance category.

(2) CMS assigns the total amount of points an ASM participant may receive for its performance on a measure or activity.

(3) CMS calculates a final score as described at § 512.745 using the points received across all four ASM performance categories.

(b) Data sources. (1) CMS uses Medicare claims data and Medicare administrative data reported to calculate measure scores included in the quality and cost ASM performance categories under §§ 512.725 and 512.730.

(2) CMS uses model-specific data reported under § 512.720 to calculate applicable measure or activity scores for the quality, improvement activities, and Promoting Interoperability ASM performance categories under §§ 512.725, 512.735, and 512.740.

(a) Applicable performance categories and data submission requirements. (1) Except as provided in paragraph (a)(2) of this section, as applicable, ASM participants must submit data on measures and activities for the quality, improvement activities, and Promoting Interoperability ASM performance categories described in §§ 512.725(b) and (c), 512.735(b), and 512.740 in accordance with this section. The data may also be submitted on behalf of the ASM participant by a third-party intermediary.

(i) For the quality ASM performance category, a data submission must—

(A) Include numerator and denominator data for at least one applicable quality measure described in § 512.725(b) or (c) that is not an administrative claims-based collection type and meets the data completeness requirement as specified at § 512.725(f) and

(B) Be submitted at the TIN/NPI level, unless the ASM participant is excepted under paragraph (f) of this section.

(ii) For the improvement activities ASM performance category, a data submission must—

(A) Include an attestation of meeting the specifications of each required improvement activity described in § 512.735(c); and

(B) Be submitted at the TIN level;

(iii) For the Promoting Interoperability ASM performance category, a data submission must do all of the following:

(A) Include all of the following elements:

(1) Performance data, including any claim of an applicable exclusion, for the measures in each objective, as specified by CMS at § 512.740(b).

(2) Required attestation statements, as specified by CMS at § 512.740(b).

(3) CMS EHR Certification ID (CEHRT ID) from the Certified Health IT Product List (CHPL).

(4) The start date and end date for the applicable performance period as set forth in § 512.740(a).

(B) Be submitted at the TIN level.

(2) There are no data submission requirements for the cost ASM performance category measures and activities described under § 512.730(b) or administrative claims-based quality measures as described in § 512.725(b) or (c). Performance in the cost ASM performance category and administrative claims-based quality measures are calculated by CMS using administrative claims data, which includes claims submitted with dates of service during the applicable performance period that are processed no later than 60 days following the close of the applicable performance period.

(b) Data submission types for ASM participants. An ASM participant must submit their data using the following:

(1) For the quality ASM performance category, the direct and login and upload submission types.

(2) For the improvement activities and Promoting Interoperability ASM performance categories, the direct, login and upload, or login and attest submission types.

(c) Use of multiple data submission types. ASM participants may submit their data using multiple data submission types for any ASM performance category described in paragraph (a)(1) of this section provided that the ASM participant uses the same identifier for all ASM performance categories and all data submissions.

(d) Data submission deadlines. The data submission deadline is March 31st of the calendar year following the close of the applicable ASM performance year or a later date as specified by CMS for the direct, login and upload, and login and attest submission types.

(e) Treatment of multiple data submissions. (1)(i) For multiple data submissions received in the quality and improvement activities ASM performance categories in accordance with paragraphs (a)(1)(i) and (ii) of this section for an individual ASM participant from submitters in multiple organizations (for example, qualified registry, practice administrator, or EHR vendor), CMS calculates and scores each submission received and assign the highest of the scores.

(ii) For multiple data submissions received for an individual ASM participant from one or multiple submitters in the same organization, CMS scores the most recent submission.

(2) For multiple data submissions received for the Promoting Interoperability ASM performance category in accordance with paragraph (a)(1)(iii) of this section, CMS calculates a score for each data submission received and assigns the highest of the scores.

(f) Small practice quality measures submission. ASM participants who are part of a small practice may report quality measures in the quality ASM performance category at the TIN level.

(a) ASM performance year for quality measures. Beginning with 2029 ASM payment year, the ASM performance year for quality measures is the full calendar year from January 1 to December 31 that occurred 2 years prior to the applicable ASM payment year, except as otherwise specified for administrative claims-based measures.

(b) Quality measures for ASM heart failure cohort. CMS uses the following quality measures, as specified by CMS for the MIPS quality performance category unless otherwise stated, to assess performance for ASM heart failure participants in the quality ASM performance category:

(1) Risk-Standardized Acute Unplanned Cardiovascular-Related Admission Rates for Patients with Heart Failure for the Merit-based Incentive Payment System (MIPS Q492).

(2) Heart Failure (HF): Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD) (MIPS Q008).

(3) Heart Failure (HF): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) or Angiotensin Receptor-Neprilysin Inhibitor (ARNI) Therapy for Left Ventricular Systolic Dysfunction (LVSD) (MIPS Q005).

(4) Controlling High Blood Pressure (MIPS Q236).

(5) Functional Status Assessments for Heart Failure (MIPS Q377).

(c) Quality measures for ASM low back pain cohort. CMS uses the following quality measures, as specified by CMS for the MIPS quality performance category unless otherwise stated, to assess performance for ASM low back pain participants in the quality ASM performance category:

(1) Use of High-Risk Medications in Older Adults (MIPS Q238).

(2) Preventive Care and Screening: Screening for Depression and Follow-Up Plan (MIPS Q134).

(3) Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan (MIPS Q128).

(4) Functional Status Change for Patients with Low Back Impairments (MIPS Q220).

(d) Removal, addition, and maintenance of technical specifications of quality measures. CMS uses notice-and-comment rulemaking to communicate any updates or changes to the quality measure sets described in paragraphs (b) and (c) of this section.

(e) Data submission criteria for the quality ASM performance category. (1) CMS uses quality measures as described in paragraphs (b) and (c) of this section with the following data collection types:

(i) MIPS CQMs.

(ii) eCQMs.

(iii) Administrative claims-based.

(2) Data submission requirements. (i) An ASM heart failure participant must submit data on all quality measures specified in paragraph (b) of this section using MIPS CQMs or eCQMs.

(ii) An ASM low back pain participant must submit data on all quality measures specified in paragraph (c) of this section using MIPS CQMs or eCQMs, unless otherwise stated.

(iii) For eCQMs, the submission of data requires the utilization of CEHRT, as defined at § 414.1305.

(3) An ASM participant is not required to submit data for the calculation of administrative claims-based measures so long as data submission requirements as specified at § 512.720(a)(1)(i) are met.

(f) Data completeness requirement for the quality ASM performance category. (1) Except as specified at paragraph (e)(3) of this section and for each required measure specified in paragraphs (b) or (c) of this section, ASM participants must submit data on at least 75 percent of the ASM participant's patients that meet the measure's denominator criteria, regardless of payer.

(2) ASM participants receive zero measure achievement points for each measure required in paragraphs (b) or (c) of this section that does not meet the data completeness requirement, as specified at paragraph (f)(1) of this section.

(3) CMS excludes from an ASM's participant total measure achievement points and total available measure achievement points any measures required under paragraphs (b) or (c) of this section that meet the respective measure's data completeness requirement, but do not have a benchmark.

(g) Minimum case requirements. (1) Unless otherwise specified by CMS, the minimum case requirement for each quality measure required in paragraphs (b) or (c) of this section is 20 cases.

(2) CMS excludes from an ASM's participant total measure achievement points and total available measure achievement points any measures required under paragraphs (b) or (c) of this section that meet the respective measure's data completeness requirement as specified at paragraph (f)(1) of this section but do not meet the measure's case minimum requirement as specified at paragraph (g)(1) of this section.

(h) Quality measure achievement points and quality ASM performance category scoring. Unless a different scoring weight is assigned by CMS, performance in the quality ASM performance category comprises of 50 percent of a ASM participant's final score for each ASM payment year.

(1) Measure achievement points. (i) For each ASM performance year, ASM participants receive between 1 and 10 measure achievement points (including partial points) for each required measure as specified in paragraphs (b) or (c) of this section on which data is submitted in accordance with paragraph (e) of this section that does all of the following:

(A) Has a benchmark specified in paragraph (h)(2) of this section.

(B) Meets the case minimum requirements specified in paragraph (g) of this section.

(C) Meets the data completeness criteria specified in paragraph (f) of this section.

(D) For each administrative claims-based measure with a benchmark as described at paragraph (h)(2)(iii) of this section and meets the case minimum requirement at paragraph (g) of this section.

(ii) The number of ASM measure achievement points received for each measure is determined based on the applicable benchmark decile category and the percentile distribution.

(iii) ASM participants receive zero ASM measure achievement points for each measure required in paragraphs (b) or (c) of this section on which no data is submitted in accordance with § 512.720.

(iv) ASM participants who submit data in accordance with paragraphs (e) through (g) of this section on a single required measure via multiple applicable collection types are scored only on the data submission with the greatest number of measure achievement points.

(2)(i) Benchmarks. Except as provided in paragraph (h)(2)(iii) of this section, CMS bases benchmarks on an ASM participant's performance by collection type, from one following data sources:

(A) Reported by ASM participants, to the extent feasible, during the ASM performance year.

(B) A previous ASM performance year, if available.

(C) Another period determined by CMS.

(ii) Each benchmark must have a minimum of 20 ASM participants who reported the measure having met the following criteria:

(A) The case minimum requirements in paragraph (g) of this section.

(B) The data completeness requirement as specified in paragraph (f) of this section.

(C) A performance rate that is greater than zero.

(iii) CMS calculates a benchmark for an administrative claims quality measure using the performance on the measure during the current ASM performance year.

(iv) CMS determines a benchmark using decile categories based on the applicable period of data used to determine the measure's benchmark.

(3) Topped out measures. CMS identifies topped out measures in the benchmarks for each ASM performance year based on within-model performance on each measure.

(4) Calculation of the quality ASM performance category score. (i) Unless otherwise specified by CMS, an ASM participant's quality ASM performance category score is the sum of all measure achievement points assigned for the applicable measures for the quality ASM performance category.

(A) The sum is divided by the total available measure achievement points.

(B) The quality ASM performance category score cannot exceed 100 percentage points.

(ii) For each measure that is submitted, if applicable, and impacted by significant changes or errors prior to the applicable data submission deadline at § 512.720(d), performance is based on data for 9 consecutive months of the applicable ASM performance year.

(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 the following:

(1) Changes to codes (such as ICD-10, CPT, or HCPCS codes) or the active status of codes.

(2) The inadvertent omission of codes or inclusion of inactive or inaccurate codes.

(3) Changes to clinical guidelines or measure specifications.

(B) CMS publishes a list of all measures scored in a form and manner specified by CMS.

(C) If the data are not available or CMS determines that they may result in patient harm or misleading results, the measure is excluded from an ASM participant's total measure achievement points and total available measure achievement points.

(iii) An ASM participant does not receive a quality ASM performance category score if the ASM participant meets the quality ASM performance category data submission requirements specified at § 512.720(a)(1)(i) but does not meet the case minimum requirements specified in paragraph (g) of this section for any required quality ASM performance category measure specified in paragraphs (b) or (c) of this section, as applicable, that has a benchmark as specified in paragraph (h)(2) of this section.

(a) ASM performance year for cost performance measures. Beginning with the 2029 ASM payment year, the ASM performance year for cost measures is the full calendar year from January 1 to December 31 that occurred 2 years prior to the applicable ASM payment year.

(b) Cost measures. For purposes of assessing performance of ASM participants on the cost ASM performance category, CMS—

(1) For ASM heart failure participants, assess and score the participants on the Heart Failure EBCM (COST_HF_1), as specified under MIPS.

(2) For ASM low back pain participants, assess and score the participants on the Low Back Pain EBCM (COST_LBP_1), as specified under MIPS.

(c) Adding or removing cost measures. CMS may add new cost measures to, or remove existing cost measures from, the cost ASM performance category through notice and comment rulemaking.

(d) Minimum case requirements. Unless otherwise specified by CMS, the minimum case requirement for each cost measure is 20 cases.

(1) Each cost measure is attributed at the TIN/NPI level according to the measure specification for the applicable ASM performance year.

(2) An ASM participant must meet the minimum case volume to be scored on a cost measure.

(e) Cost measure achievement points and cost ASM performance category scoring. Unless a different scoring weight is assigned by CMS, performance in the cost ASM performance category comprises 50 percent of an ASM participant's final score for each ASM performance year.

(1) ASM measure achievement points. (i) For each cost measure attributed to an ASM participant, the ASM participant receives one to ten achievement points (including partial points) based on the ASM participant's performance on the cost measure during the ASM performance year compared to the cost measure's benchmark.

(i) Achievement points are awarded based on which benchmark range the ASM participant's performance on the measure is in.

(2) Benchmarks (i) CMS bases cost measure benchmarks on cost measure performance during the ASM performance year.

(A) Each benchmark must have a minimum of 20 ASM participants who meet the minimum case volume specified in paragraph (d) of this section for CMS to determine a benchmark for the cost measure.

(B) If a benchmark is not determined for a cost measure, then the measure is not scored.

(ii) CMS determines 10 benchmark ranges based on the median cost of all ASM participants attributed the measure, plus or minus standard deviations. CMS awards achievement points based on which benchmark range an ASM participant's measure score corresponds.

(3) Calculation of the cost ASM performance category score. Except as otherwise specified in paragraph (e)(3)(i) of this section, the cost ASM performance category score is the sum of the total number of achievement points earned by the ASM participant divided by the total number of available achievement points, not to exceed 100 percent.

(i) An ASM participant does not receive a cost ASM performance category score if the ASM participant is not attributed the required cost measure for the ASM performance year specified in paragraph (b) of this section because the ASM participant has not met the case minimum specified in paragraph (d) of this section for the required cost measure or if a benchmark has not been created for a required cost measure as specified in paragraph (e)(2) of this section.

(ii) If data used to calculate a score for a cost measure are impacted by significant changes or errors affecting the ASM performance year, such that calculating the cost measure score would lead to misleading or inaccurate results, then the affected cost measure is excluded from the ASM participant's cost ASM performance category score and a cost ASM performance category score is not calculated.

(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.

(B) 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.

(C) CMS empirically assesses 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.

(a) ASM performance year for improvement activities. Beginning with the 2029 ASM payment year, the ASM performance year for improvement activities is a minimum of a continuous 90-day period within the calendar year that occurs 2 years prior to the applicable ASM payment year, up to and including the full calendar year.

(b) Improvement activities. CMS uses the improvement activities specified in paragraph (c) of this section to evaluate performance of ASM participants in the improvement activities ASM performance category.

(c) Improvement activities specifications—(1) Improvement Activity 1 (IA-1): Connecting to Primary Care and Ensuring Completion of Health-Related Social Needs Screening. An ASM participant must have evidence of processes, workflows, or technology that require the ASM participant to do all of the following:

(i) Confirm the ASM beneficiary has access to primary care services and, if not, assist the ASM beneficiary in finding a clinician who provides primary care services.

(ii) Communicate relevant information back to the ASM beneficiary's primary care provider following the ASM beneficiary's visit with the ASM participant.

(iii) Determine whether the ASM beneficiary has received an annual health-related social needs screening in the primary care setting and, if not, encourage the primary care services provider to conduct the screening or allow the ASM participant to conduct the health-related social needs screening.

(2) Improvement Activity 2 (IA-2): Establishing Communication and Collaboration Expectations with Primary Care using Collaborative Care Arrangements. An ASM participant must do all of the following:

(i) Have at least one executed collaborative care arrangement between a primary care practice with which the ASM participant shares ASM beneficiaries.

(ii) The collaborative care arrangement must include collaborative efforts related to at least three of the following five elements:

(A) Data sharing, which includes setting expectations for bi-directional sharing of patient information between the parties to the collaborative care arrangement, including but not limited to test results, treatment plans, and follow-up recommendations.

(B) Co-management, which includes defining co-management approaches, where the parties to the collaborative care arrangement work together to furnish complementary care for patients with complex or chronic conditions.

(C) Transitions in care planning, which includes defining protocols for seamless transitions of care between ASM participants, the primary care practice, or different care settings.

(D) Closed-loop communication, such as clearly articulated processes enforcing parameters on how ASM beneficiaries may be referred between the parties to the collaborative care arrangement.

(E) Care coordination integration comprised of structured processes to embed care coordination processes into the ASM participant's practice workflow.

(d) Scoring for improvement activities ASM performance category—(1) ASM measure achievement points. ASM participants receive 10 ASM measure achievement points for attesting “yes” for each improvement activity specified in paragraph (c) in compliance with the data submission requirements at § 512.720.

(2) Calculation of the improvement activities ASM performance category score. Unless otherwise specified by CMS, CMS sums the total achievement points for all submitted improvement activities and divides this sum by the total number of available achievement points for the required improvement activities as specified in paragraph (c) of this section, not to exceed 100 percent.

(a) ASM performance year for the Promoting Interoperability ASM performance category. Beginning with the 2029 ASM payment year, the ASM performance year for Promoting Interoperability measures is the minimum of a continuous 180-day period within the calendar year that occurs 2 years prior to the applicable ASM payment year, up to and including the full calendar year.

(b) Reporting for the Promoting Interoperability ASM performance category. To earn an ASM performance category score greater than zero for the Promoting Interoperability ASM performance category for inclusion in the final score, an ASM participant must be a meaningful EHR user and meet the following criteria:

(1) CEHRT. Use CEHRT as defined at § 414.1305 for the ASM performance year.

(2) ASM Promoting Interoperability objectives and measures. Report on the following MIPS Promoting Interoperability measures, as specified by CMS through rulemaking:

(i) An ASM Participant must report both of the following measures or claim an exclusion or exclusions to fulfill the e-Prescribing objective:

(A) e-Prescribing (Measure ID #: PI_EP_1).

(B) Query of PDMP (Measure ID # PI_EP_2).

(ii) An ASM Participant must fulfill the Health Information Exchange objective through one of the following three options:

(A) Report the Support Electronic Referral Loops by Sending Health Information (Measure ID # PI_HIE_1) and Support Electronic Referral Loops by Receiving and Reconciling Health Information (Measure ID # PI_HIE_4).

(B) Health Information Exchange (HIE) Bi-Directional Exchange (Measure ID # PI_HIE_5).

(C) Enabling Exchange Under the Trusted Exchange Framework and Common Agreement (TEFCA) (Measure ID # PI_HIE_6).

(iii) An ASM Participant must fulfill the Provider to Patient Exchange objective by reporting the Provide Patients Electronic Access to Their Health Information measure (Measure ID # PI_PEA_1).

(iv) An ASM Participant must fulfill the Public Health and Clinical Data Exchange objective by reporting both measures:

(A) Immunization Registry Reporting (Measure ID # PI_PHCDDR_1).

(B) Electronic Case Reporting (Measure ID PI_PHCDRR_3).

(3) Reporting ASM Promoting Interoperability objectives and measures. Comply with the following reporting requirements:

(i) For each measure under paragraph (b)(2) of this section, report—

(A) The numerator (of at least one) and denominator;

(B) Yes/no statement; or

(C) An exclusion that includes an option for the exclusion.

(ii) Report that the ASM participant completed the actions included in the MIPS Promoting Interoperability Security Risk Analysis measure (Measure ID # PI_PPHI_1) within the calendar year of the ASM performance year.

(iii) Submit an affirmative attestation regarding the ASM participant's completion of the annual self-assessment checklist under the MIPS Promoting Interoperability High Priority Practices Guide of the SAFER Guides measure (Measure ID # PI_PPHI_2) within the calendar year of the ASM performance year.

(4) Supporting use of CEHRT. ASM participants must support the use of CEHRT by fulfilling the following requirements:

(i) Supporting the use and performance of CEHRT. To fulfill ASM requirements to engage in activities related to supporting clinicians with the performance of CEHRT, the ASM participant:

(A) Must attest by providing all of the following:

(1) Acknowledgement of the requirement to cooperate in good faith with ONC direct review of the ASM participant's health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC direct review is received.

(2) If requested, cooperation in good faith with ONC direct review of the ASM participant's health information technology certified under the ONC Health IT Certification Program as authorized by 45 CFR part 170, subpart E, to the extent that the technology meets, or can be used to meet, the definition of CEHRT, including by permitting timely access to the technology and demonstrating its capabilities as implemented and used by the ASM participant in the field.

(B) May attest to the following objectives and measures:

(1) Acknowledgement of the option to cooperate in good faith with ONC-ACB surveillance of his or her health information technology certified under the ONC Health IT Certification Program if a request to assist in ONC-ACB surveillance is received.

(2) If requested, cooperation in good faith with ONC-ACB surveillance of the ASM participant's health information technology certified under the ONC Health IT Certification Program as authorized by 45 CFR part 170, subpart E, to the extent that the technology meet, or can be used to meet, the definition of CEHRT, including by permitting timely access to the technology and demonstrating its capabilities as implemented and used by the ASM participant in the field.

(ii) Actions to limit or restrict the compatibility or interoperability of CEHRT. To fulfill ASM requirements for activities related to limiting or restricting the compatibility or interoperability of CEHRT, the ASM participant must not knowingly and willfully take action, such as to disabling functionality, to limit or restrict the compatibility or interoperability of CEHRT.

(c) Scoring the Promoting Interoperability ASM performance category—(1) ASM measure achievement points.

(i) An ASM participant earns a score for each measure by fulfilling the reporting requirements specified at paragraph (b) of this section. Score amounts are set forth in the MIPS measure specifications.

(ii) If an exclusion is reported for a measure, the points available for that measure are redistributed to another measure as set forth in the MIPS measure specifications.

(2) Promoting Interoperability ASM performance category score. Unless otherwise specified by CMS, CMS sums the scores for each of the required measures and divides this sum by the total number of available Promoting Interoperability points. The Promoting Interoperability ASM performance category score cannot exceed 100 percent.

(a) Final score calculation. CMS calculates a final score of zero to 100 points using the formula specified at paragraph (a)(5) of this section for each ASM participant that meets the requirements to receive a final score as specified in paragraph (a)(2) of this section.

(1) ASM performance category weights and scoring adjustments. CMS calculates the final score using the ASM performance category weights and scoring adjustments as follows:

(i) Quality ASM performance category weight is 50 percent.

(ii) Cost ASM performance category weight is 50 percent.

(iii) The improvement activities ASM performance category has a scoring adjustment that is applied to the final score without weighting.

(A) ASM participants that achieve a 100 percent score for the improvement activities ASM performance category do not receive an improvement activities ASM performance category scoring adjustment to final score.

(B) ASM participants that receive a 50 percent improvement activities ASM performance category score receive an improvement activities ASM performance category scoring adjustment of negative 10 points to the final score.

(C) ASM participants that receive a zero percent improvement activities ASM performance category score receive an improvement activities ASM performance category scoring adjustment of negative 20 points to the final score.

(iv) The Promoting Interoperability ASM performance category has a scoring adjustment that is applied to the final score without weighting.

(A) To determine the Promoting Interoperability ASM performance category scoring adjustment as described in paragraph (a)(1)(iv) of this section, the Promoting Interoperability ASM performance category score is multiplied by 100, the product is then subtracted from 100 and divided by the maximum negative Promoting Interoperability ASM performance category scoring adjustment of 10 points.

(B) The maximum Promoting Interoperability ASM performance category scoring adjustment is negative 10 points.

(2) Requirements to receive a final score. Except as described at § 512.780(c)(1), CMS determines whether an ASM participant receives a final score for the applicable ASM performance year depending on the data submitted by the ASM participant.

(i) Except as described in paragraph (a)(2)(iii) of this section, CMS calculates a final score greater than zero but not exceeding 100 as described in paragraph (a) of this section for the applicable ASM performance year for all ASM participants that meet the quality ASM performance category data submission requirements as specified at § 512.720(a)(1)(i).

(ii) CMS assigns a final score of zero for the applicable ASM performance year to all ASM participants who do not meet the quality ASM performance category data submission requirements as specified at § 512.720(a)(1)(i).

(iii) CMS does not assign a final score for the applicable ASM performance year to ASM participants who do all of the following:

(A) Meet the quality ASM performance category data submission requirements as specified at § 512.720(a)(1)(i).

(B)(1) Do not receive a quality ASM performance category score under § 512.725(h)(4)(iii); or

(2) Do not receive a cost ASM performance category score under § 512.730(e)(3)(i).

(3) Complex patient scoring adjustment. CMS adds a complex patient scoring adjustment to the final score for the ASM performance year, if applicable, if an ASM participant meets the requirements to receive a final score greater than zero as described in paragraph (a)(2)(i) of this section and the criteria defined in paragraph (a)(3)(i) of this section for the applicable ASM performance year.

(i) The complex patient scoring adjustment is limited to ASM participants with a risk indicator at or above the risk indicator calculated median for their ASM cohort. To determine the median for the respective risk indicator (HCC and dual eligible proportion) for each ASM cohort, risk indicators associated to an ASM participant in the corresponding ASM cohort from the calendar year preceding the applicable ASM performance year, for all ASM participants within an ASM cohort who meet the data submission requirements for the quality ASM performance category at § 512.725(a)(1)(i) are used.

(ii) Beginning with the 2027 ASM performance year, for ASM participants, the complex patient scoring adjustment components are calculated as follows for the specific risk indicators:

(A) Medical complex patient scoring adjustment component = 1.5 + 4 * associated HCC standardized score calculated with the average HCC risk score assigned to beneficiaries (under the HCC risk adjustment model established by CMS in accordance with section 1853(a)(1) of the Act) seen by the ASM participant.

(B) Social complex patient scoring adjustment component = 1.5 + 4 * associated dual proportion standardized score.

(C) The components specified in paragraphs (a)(3)(ii)(A) and (B) of this section are added together to calculate one overall complex patient scoring adjustment. 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.

(iii) The complex patient scoring adjustment cannot exceed 10 and cannot be below zero.

(4) Small practice scoring adjustment—(i) Scoring adjustment for an ASM participant that is in a small practice and is not a solo practitioner. CMS add 10 points to the final score of an ASM participant that meets all of the following:

(1) Is in a small practice.

(2) Is not a solo practitioner.

(3) Meets the requirements to receive a final score greater than zero as described in paragraph (a)(2)(i) of this section for an applicable ASM performance year.

(ii) Scoring adjustment for ASM participant that is a solo practitioner. CMS adds 15 points to the final score of an ASM participant that is a solo practitioner and meets the requirements to receive a final score greater than zero as described in paragraph (a)(2)(i) of this section for an applicable ASM performance year.

(5) Final score formula. Final score = [quality ASM performance category score × quality ASM performance category weight) + (cost ASM performance category score × cost ASM performance category weight)] × 100 + improvement activities ASM performance category scoring adjustment + Promoting Interoperability ASM performance category scoring adjustment + complex patient scoring adjustment + small practice scoring adjustment. The final score cannot be below zero points or exceed 100 points.

(b) ASM performance report. For each ASM performance year, CMS provides each ASM participant with an ASM performance report, in a form and manner determined by CMS, containing all of the following:

(1) The ASM participant's score for each ASM performance category.

(2) The ASM participant's complex patient scoring adjustment under paragraph (a)(3) of this section, as applicable.

(3) The ASM participant's small practice or solo practitioner scoring adjustment under paragraph (a)(4) of this section, as applicable.

(4) The ASM participant's final score, as applicable.

(5) The ASM payment adjustment factor under § 512.750(c)(1).

(6) The ASM payment multiplier under § 512.750(c).

(a) General. Except as described in paragraph (f) of this section, for covered professional services furnished by an ASM participant during an ASM payment year, CMS, in accordance with paragraph (d) of this section, multiplies the amount otherwise paid under Part B for the covered professional services by the ASM payment multiplier calculated for the ASM participant calculated under paragraph (c) of this section for the corresponding ASM performance year.

(b) Comparison of ASM participant performance. For the purpose of determining ASM payment adjustment factors and ASM payment multipliers applicable to adjustments to Part B payments for covered professional services in the corresponding ASM payment year, CMS separately compares final scores of ASM participants in each ASM cohort for the corresponding ASM performance year.

(c) ASM payment multiplier. Unless otherwise specified under paragraph (d) of this section, for each ASM participant within an ASM cohort for the applicable ASM payment year, CMS calculates an ASM payment multiplier as 1 plus the ASM payment adjustment factor determined under paragraph (c)(1) of this section.

(1) ASM payment adjustment factor. For each ASM participant with a final score greater than zero as described at § 512.745(a)(2)(i) within an ASM cohort for the applicable ASM performance year, CMS calculates an ASM payment adjustment factor using the formula: ASM payment adjustment factor = [(ASM risk level as described in paragraph (c)(1)(i) of this section) × (ASM participant's transformed final score as described in paragraph (c)(1)(ii) of this section) × (scaling factor applicable to the ASM incentive pool as described in paragraph (c)(1)(iv) of this section)]—ASM risk level as described in paragraph (c)(1)(i) of this section. For each ASM participant with a final score equal to zero as described at § 512.745(a)(2)(ii) within an ASM cohort for the applicable ASM payment year, CMS calculates an ASM payment adjustment factor equal to the negative of the applicable ASM level risk level as described in paragraph (c)(1)(i) of this section.

(i) ASM risk level. CMS sets an ASM risk level that is the magnitude of the maximum downside and upside risk to which an ASM participant would be subject to during an ASM payment year.

(A) For the 2029 ASM payment year, the ASM risk level is 9 percent.

(B) For the 2030 ASM payment year, the ASM risk level is 9 percent.

(C) For the 2031 ASM payment year, the ASM risk level is 10 percent.

(D) For the 2032 ASM payment year, the ASM risk level is 11 percent.

(E) For the 2033 ASM payment year, the ASM risk level is 12 percent.

(ii) Exchange function and transformed final score. CMS uses a logistic exchange function with a midpoint set at the median final score of the applicable ASM cohort from the applicable ASM performance year to transform each ASM's participant final score into a numerical value.

(iii) Incentive pool. CMS calculates an ASM incentive pool for each ASM cohort for an applicable ASM payment year using the formula: ASM incentive pool = (Sum of Medicare Part B payments for covered professional services paid to ASM participants with final scores in an ASM cohort during the applicable ASM performance year) × (ASM risk level as defined in paragraph (c)(1)(i) of this section) × (ASM redistribution percentage). The ASM redistribution percentage is set at 85 percent.

(iv) Scaling factor. CMS calculates a scaling factor for each ASM incentive pool for the applicable ASM payment year that ensures the estimated total payment adjustments would equal the ASM incentive pool. The scaling factor is calculated by dividing the total amount in the ASM incentive pool by the sum of all ASM participant's transformed final scores, multiplied by their respective total Medicare Part B covered professional services payments from the applicable ASM performance year and the applicable ASM risk level as specified under paragraph (c)(1)(i) of this section.

(2) [Reserved]

(d) No payment adjustments. CMS assigns an ASM payment adjustment factor of 0 and an ASM payment multiplier of 1 for the applicable ASM payment year that results in no payment adjustment to an ASM participant who does not receive a final score under § 512.745(a)(2)(iii) for the corresponding ASM performance year.

(e) Notification of ASM payment adjustments to ASM participants. CMS notifies each ASM participant of their ASM payment adjustment factor and corresponding ASM payment multiplier for the applicable ASM payment year in the ASM performance report under § 512.745(b) provided to each ASM participant for the applicable ASM performance year.

(f) Change in ASM participant TIN affiliation after ASM performance year and before the end of corresponding ASM payment year. (1) CMS adjusts payments to the different TIN using the ASM payment multiplier calculated for the ASM participant based on their performance in the corresponding ASM performance year for an NPI who meets all of the following:

(i) Is an ASM participant with a final score for an ASM performance year.

(ii) Submits Part B covered professional service claims during an ASM payment year using a different TIN than the TIN CMS identified them as an ASM participant for that ASM performance year and to which the ASM participant began assigning billing rights after the applicable ASM performance year but before the end of the corresponding ASM payment year.

(2) CMS adjusts claims using the highest ASM payment multiplier from all the TIN and NPI combinations that identified the NPI as an ASM participant for the corresponding ASM performance year for an NPI who meets all of the following:

(i) CMS identifies as an ASM participant under multiple TINs for a given ASM performance year.

(2) Submits Part B covered professional service claims during an ASM payment year under a TIN by which CMS did not identify the ASM participant and to which the ASM participant began assigning billing rights after the applicable ASM performance year but before the end of the corresponding ASM payment year.

(a) General. Subject to the limitations on review in § 512.170, an ASM participant may submit a written timely error notice for one or more calculations made and issued by CMS within the ASM performance report if the ASM participant believes an error occurred in calculations due to data quality, misapplication of methodology, or other issues.

(b) Requirements. If an ASM participant believes the ASM performance report contains a calculation error as described in paragraph (a) of this section, the ASM participant must submit a written timely error notice, in a form and manner specified by CMS, documenting the calculation error within 30 calendar days of issuance of the ASM performance report, unless specified by CMS.

(1) If the ASM participant does not provide written timely error notice in accordance with paragraph (a) of this section, then the ASM performance report is deemed final 30 calendar days after its issuance.

(2) Only an ASM participant may submit a written timely error notice described in this section.

(3) Sufficiency of information in written timely error notice.

(i) CMS determines if the written timely error notice meets the requirements of this section and contains sufficient information to substantiate the request.

(ii) If the request is not compliant with the requirements of this section or requires additional information—

(A) CMS follows up with the ASM participant to request additional information in a form and manner as specified by CMS;

(B) The ASM participant must respond within 10 calendar days of CMS' request for additional information in a form and manner as specified by CMS; and

(C) If an ASM participant does not respond in accordance with paragraph (b)(3)(ii)(B) of this section, then the ASM performance report is deemed final.

(c) Process. (1) If CMS receives a written timely error notice within 30 calendar days of the issuance of the ASM performance report that CMS determines meets the requirements of paragraph (b) of this section, CMS issues an initial determination in writing within 30 calendar days of receipt to either confirm that there was an error in the calculation or verify that the calculation is correct.

(2) CMS reserves the right to extend the time for providing its initial final determination upon written notice to the ASM participant.

(d) Reconsideration request. An ASM participant who wishes to dispute an initial determination made in accordance with paragraph (c) of the section may invoke the reconsideration review process under § 512.190.

(a) General. CMS shares certain beneficiary-identifiable data as described in paragraphs (b), (c), and (e) of this section and certain aggregate data as described in paragraph (d) of this section with ASM participants regarding ASM beneficiaries and performance under the model.

(b) Beneficiary-identifiable data. CMS shares beneficiary-identifiable data with ASM participants as follows:

(1) CMS makes available certain beneficiary-identifiable data described in paragraph (b)(5) of this section for ASM participants to request for purposes of conducting health care operations work that falls within the first or second paragraph of the definition of health care operations at 45 CFR 164.501 on behalf of their patients who are ASM beneficiaries.

(2) An ASM participant that wishes to receive beneficiary-identifiable data for its ASM beneficiaries must do all of the following:

(i) Submit a formal request for the data, on at least an annual basis in a manner and form and by a date specified by CMS, which identifies the data being requested and attests that—

(A) The ASM participant is requesting this beneficiary-identifiable data as part of a covered entity, as defined at 45 CFR 160.103;

(B) The ASM participant's request reflects the minimum data necessary, as set forth in paragraph (c) of this section, for the ASM participant to conduct activities described in the first or second paragraph of the definition of health care operations at 45 CFR 164.501; and

(C) The ASM participant's use of beneficiary-identifiable data is limited to developing processes and engaging in appropriate activities related to coordinating care, improving the quality and efficiency of care, and conducting population-based activities relating to improving health or reducing health care costs that are applied uniformly to all ASM beneficiaries under the care of the ASM participant, and that these data are not to be used to reduce, limit or restrict care for specific Medicare beneficiaries.

(ii) To the extent practicable, limit the request to ASM beneficiaries whose claims were used to determine the requesting ASM participant's eligibility for ASM participation or to whom the requesting ASM participant provided care during an applicable ASM performance year.

(iii) Sign and submit a data sharing agreement with CMS as set forth in paragraph (e)(1) of this section.

(3) CMS shares beneficiary-identifiable data with an ASM participant on the condition that the ASM participant and other individuals or entities performing functions or services related to the ASM participant's activities, including but not limited to non-ASM participant parties in collaborative care arrangements with ASM participants, comply with all appliable laws addressing the appropriate use of data and the confidentiality and privacy of individually identifiable health information and the terms of the data sharing agreement described in paragraph (e)(1) of this section.

(4) CMS omits from the beneficiary-identifiable data any information that is subject to the regulations in 42 CFR part 2 governing the confidentiality of substance use disorder patient records.

(5) The beneficiary-identifiable data includes, when available, the following information:

(i) Unrefined (raw) Medicare Parts A, B, and D beneficiary-identifiable claims data used to determine ASM participant eligibility for an applicable ASM performance year; and

(ii) Unrefined (raw) Medicare Parts A, B, and D beneficiary-identifiable claims data for ASM beneficiaries who trigger an applicable EBCM episode with the ASM participant during the applicable ASM performance year.

(c) Minimum necessary data. The ASM participant must limit its request for beneficiary-identifiable data under paragraph (b) of this section to the minimum necessary to accomplish the permitted use of the data. The minimum necessary Medicare Parts A, B, and D data elements may include, but are not limited to the following:

(1) Medicare beneficiary identifier (ID).

(2) Procedure code.

(3) Sex.

(4) Diagnosis code.

(5) Claim ID.

(6) The from and through dates of service.

(7) The provider or supplier ID.

(8) The claim payment type.

(9) Date of birth and death, if applicable.

(10) Tax identification number.

(11) National provider identifier.

(d) Aggregated data feedback. CMS shares aggregated data on one or more select indicators of the ASM participant's performance, de-identified in accordance with 45 CFR 164.514(b), in a form and manner to be specified by CMS, when available, with ASM participants.

(e) ASM data sharing agreement. (1) To retrieve the beneficiary-identifiable data specified in paragraphs (b) and (c) of this section, the ASM participant must complete and submit, on at least an annual basis, a signed ASM data sharing agreement, to be provided in a form and manner and by a date specified by CMS, under which the ASM participant agrees, at a minimum to do all of the following:

(i) Comply with the requirements for use and disclosure of this beneficiary identifiable data that are imposed on covered entities by the HIPAA regulations, including but not limited to 45 CFR part 164, subparts A and E, and the requirements of ASM set forth in this part.

(ii) Comply with additional privacy, security, breach notification, and data retention requirements specified by CMS in the ASM data sharing agreement.

(iii) Contractually bind any and all downstream recipients of this beneficiary identifiable data, such as other individuals or entities performing functions or services related to the ASM participant's data sharing activities, including those that meet the definition of a business associate as defined at 45 CFR 160.103 and non-ASM participant parties to collaborative care arrangements described at § 512.771, to the same terms and conditions to which the ASM participant is itself bound in its data sharing agreement with CMS as a condition of the business associate's or non-ASM participant parties' receipt of the beneficiary-identifiable data obtained by the ASM participant.

(iv) That if the ASM participant or any downstream recipient misuses or discloses the beneficiary-identifiable data in a manner that violates any applicable statutory or regulatory requirements or that is otherwise non-compliant with the provisions of the data sharing agreement, CMS may do any or all of the following:

(A) Deem the ASM participant ineligible to obtain the beneficiary-identifiable data under paragraph (b) of this section for any amount of time.

(B) Subject the ASM participant to additional sanctions and penalties available under applicable law.

(v) An ASM participant must comply with all applicable laws and the terms of the data sharing agreement to obtain beneficiary-identifiable data.

(2) CMS shares beneficiary-identifiable data with an ASM participant on the condition that the ASM participant and other individuals or entities performing functions or services related to the ASM participant's data sharing activities, including business associates as defined at 45 CFR 160.103 of the ASM participant and non-ASM participant parties to collaborative care arrangements described at § 512.771, comply with all relevant laws governing the use of data and the privacy and security of individually identifiable health information and the terms of the data sharing agreement described in paragraph (e)(1) of this section.

(f) Data custodian. An ASM participant must designate and provide the contact information for, in a form and manner identified by CMS, a data custodian who is responsible for ensuring compliance with privacy and security requirements, including all applicable laws and terms of the ASM data sharing agreement, and for notifying CMS of any incidents relating to unauthorized disclosures of beneficiary-identifiable data.

(a) Application of the CMS-sponsored model arrangements safe harbor. CMS has determined that the Federal anti-kickback statute safe harbor for CMS-sponsored model arrangements (§ 1001.952(ii)(1)) is available to protect remuneration furnished in accordance with the collaborative care arrangements that meet all safe harbor requirements set forth in §§ 1001.952(ii) and 512.771.

(b) Application of the CMS-sponsored model patient incentives safe harbor. CMS has determined that the Federal anti-kickback statute safe harbor for CMS-sponsored model patient incentives (§ 1001.952(ii)(2)) is available to protect remuneration furnished in ASM in the form of ASM beneficiary engagement incentives that meet all safe harbor requirements set forth in §§ 1001.952(ii) and 512.770.

(a) ASM beneficiary incentives. ASM participants may choose to provide in-kind patient engagement incentives, including but not limited to items of technology or services, to ASM beneficiaries, subject to the following conditions:

(1) Provision of incentive. (i) The incentive must be provided directly by the ASM participant or by an agent of the ASM participant under the ASM participant's direction and control to an ASM beneficiary who is an established patient of the ASM participant.

(ii) The ASM participant must be solely responsible for any costs associated with the provision of the incentive, including but not limited to, the retail value of the item or services offered as the ASM beneficiary incentive.

(2) The item or service provided must be reasonably connected to medical care provided by the ASM participant to an ASM beneficiary for an ASM targeted chronic condition.

(3) The item or service must be a preventive care item or service or an item or service that advances a clinical goal, as specified in paragraph (d) of this section, for an ASM beneficiary by engaging the ASM beneficiary in better managing an ASM targeted chronic condition.

(4) The item or service must not be tied to the receipt of items or services outside the services furnished by the ASM participant to the ASM beneficiary.

(5) The item or service must not be tied to the receipt of items or services from a particular provider or supplier.

(6) The availability of the items or services must not be advertised or promoted, except that an ASM beneficiary may be made aware of the availability of the items or services at the time the ASM beneficiary could reasonably benefit from them.

(7) The cost of the items or services must not be shifted to any Federal health care program, as defined at section 1128B(f) of the Act.

(8) The totality of items or services, including technology as described at paragraph (b) of this section, provided to an ASM beneficiary may not exceed $1,000 in retail value for any one ASM beneficiary.

(b) Technology provided to an ASM beneficiary. ASM beneficiary incentives involving technology are subject to the following additional conditions:

(1) Items or services involving technology provided to an ASM beneficiary must be the minimum necessary to advance a clinical goal, as listed in paragraph (d) of this section, for an ASM beneficiary.

(2) Items of technology exceeding $75 in retail value must—

(i) Remain the property of the ASM participant; and

(ii) Be retrieved from the ASM beneficiary—

(A) Upon the end of their care relationship with the ASM participant, with documentation of the ultimate date of retrieval. The ASM participant must document all retrieval attempts.

(1) In cases when the item of technology is not able to be retrieved, the ASM participant must determine why the item was not retrievable.

(2) If it was determined that the item was misappropriated, then the ASM participant must take steps to prevent future beneficiary incentives for that ASM beneficiary.

(3) Following this process, documented, diligent, good faith attempts to retrieve items of technology is deemed to meet the retrieval requirement; or

(B) If the provided technology breaks or is otherwise rendered unusable for its intended purposes, with documentation of the ultimate date of retrieval. The ASM participant may replace the unusable unit with the same or similar technology, to the extent practicable, that meets the requirements of paragraphs (a) and (b) of this section.

(c) Documentation of ASM beneficiary incentives. In addition to requirements at § 512.135 of this part ASM participants must do all of the following:

(1) Maintain documentation of items and services furnished as beneficiary incentives that exceed $75 in retail value.

(2) The documentation must be established contemporaneously with the provision of the items and services with a record established and maintained to include at least the following:

(i) The date the incentive is provided.

(ii) The identity of the ASM beneficiary to whom the item or service was provided.

(3) The documentation regarding items of technology exceeding $75 in retail value must also include contemporaneous documentation of any attempt to retrieve technology at the end of an episode, or why the items were not retrievable, as described in paragraph (b)(2)(ii) of this section.

(4) The ASM participant must retain and provide access to the required documentation.

(d) Clinical goals of ASM. The following are the clinical goals of ASM, which may be advanced through ASM beneficiary incentives:

(1) Promoting preventive care through improved management of ASM targeted chronic conditions.

(2) Empowering patients to actively participate and be accountable for quality and whole health outcomes.

(3) Facilitating meaningful and efficient coordination between specialists and primary care providers to increase independent physician participation in value-based payment programs.

(a) General. Collaborative care arrangements must meet all of the following:

(1) Be in writing, signed by both parties, and contain the effective date of the arrangement.

(2) Be exclusively between the ASM participant and the primary care practice with whom the ASM participant shares at least one established patient who is an ASM beneficiary.

(3) The collaborative care arrangement must be entered into for the purpose of either of the following:

(i) Furthering the ASM participant's performance in the improvement activities ASM performance category at § 512.735.

(ii) Advancing the clinical goals of ASM as described in paragraph (b) of this section.

(4) Participation in a collaborative care arrangement must be voluntary and without penalty for nonparticipation.

(5) Both parties to the collaborative care arrangement must comply with all applicable statutes, regulations, and guidance, including without limitation the following:

(i) Federal criminal laws.

(ii) The False Claims Act (31 U.S.C. 3729 et seq.).

(iii) The anti-kickback statute (42 U.S.C. 1320a-7b(b)).

(iv) The civil monetary penalties law (42 U.S.C. 1320a-7a).

(v) The physician self-referral law (42 U.S.C. 1395nn).

(6) The opportunity to enter into a collaborative care arrangement, and the amount of any payment under a collaborative care arrangement, must not be conditioned directly or indirectly on the volume or value of past or anticipated referrals or business generated by, between, or among the parties to the collaborative care arrangement or any other person.

(7) Any payment between the parties set forth in a collaborative care arrangement must not exceed the sum total of the payment adjustments made to an ASM participant's claims for a given ASM performance year as a result of the application of the ASM payment adjustment factor to the ASM participant's Medicare Part B payments for covered professional services during an ASM payment year.

(8) Any payment or other remuneration set forth in the collaborative care arrangement must be solely between the parties to the arrangements. Any payment between the parties must be made by check, electronic funds transfer, or another traceable cash transaction.

(9) Both parties to the collaborative care arrangement must retain the ability to make decisions in the best interests of ASM beneficiaries, including the selection of clinicians, devices, supplies, and treatments.

(10) The collaborative care arrangement must not do either of the following:

(i) Induce any party to reduce or limit medically necessary services to any Medicare beneficiary.

(ii) Reward the provision of items and services that are medically unnecessary.

(11) ASM participants must maintain contemporaneous documentation, in accordance with § 512.135, regarding all collaborative care arrangements entered into, including the following:

(i) The relevant written agreements.

(ii) The date and amount of any payments between the parties.

(iii) A description of the methodology and accounting formula for determining the amount of any payments between the parties.

(12) The collaborative care arrangement must stipulate that any non-ASM participant party is considered a downstream recipient for CMS data sharing purposes, and must require the non-ASM participant party to comply with applicable data sharing requirements at § 512.760.

(13) Any non-ASM participant party to a collaborative care arrangement must be a downstream participant subject to the standard provisions for Innovation Center models specified in subpart A of this part 512.

(b) Clinical goals of ASM. The following are the clinical goals of ASM, which may be advanced through collaborative care arrangements:

(1) Promoting preventive care through improved management of ASM targeted chronic conditions.

(2) Empowering patients to actively participate and be accountable for quality and whole health outcomes.

(3) Facilitating meaningful and efficient coordination between specialists and primary care providers to increase independent physician participation in value-based payment programs.

(c) Collaborative care arrangement exclusions. An ASM participant may not enter into a collaborative care arrangement with a party that is excluded from participation in any Federal health care programs by the Inspector General.

(a) Medicare payment waivers. Unless otherwise specified in § 512.710(a)(2), CMS waives the requirements of section 1848(q) of the Act, and its implementing regulations, for an ASM participant for each ASM performance year that the ASM participant meets the ASM eligibility criteria set forth in § 512.710(b)(1).

(b) Waiver of certain telehealth requirements—(1) Waiver of the geographic site requirements. Except for the geographic site requirements for a face-to-face encounter for home health certification, CMS waives the geographic site requirements of section 1834(m)(4)(C)(i)(I) through (III) of the Act for ASM participants and ASM beneficiaries solely for services that—

(i) May be furnished via telehealth under existing Medicare program requirements; and

(ii) Are medically appropriate for treatment of an ASM targeted chronic condition.

(2) Waiver of the originating site requirements. Except for the originating site requirements for a face-to-face encounter for home health certification, CMS waives the originating site requirements under section 1834(m)(4)I(ii)(I) through (VIII) of the Act for episodes to permit a telehealth visit to originate in the beneficiary's home or place of residence solely for services that—

(i) May be furnished via telehealth under existing Medicare program requirements; and

(ii) Are medically appropriate for treatment of an ASM targeted chronic condition.

(3) Waiver of selected payment provisions. CMS waives payment requirements as follows:

(i) Under section 1834(m)(2)(A) of the Act so that the facility fee normally paid by Medicare to an originating site for a telehealth service is not paid if the service is originated in the beneficiary's home or place of residence.

(ii) Under section 1834(m)(2)(B) of the Act to allow the distant site payment for telehealth home visit HCPCS codes unique to ASM.

(4) Other requirements. All other requirements for Medicare coverage and payment of telehealth services continue to apply, including the list of specific services approved to be furnished by telehealth.

(a) General rule. Except as specified in paragraph (b) of this section, CMS—

(1) Applies determinations made under the Quality Payment Program for whether an extreme and uncontrollable circumstance has occurred and the affected area during the ASM performance year; and

(2) Has sole discretion to determine the period during which an extreme and uncontrollable circumstance occurred.

(b) Additional criteria. (1) CMS has sole discretion to determine, based on information known to the agency prior to the beginning of the relevant ASM payment year, that data for an ASM participant are inaccurate, unusable, or otherwise compromised due to circumstances outside of the control of the clinician and its agents, including third-party intermediaries.

(2) CMS notifies ASM participants of the following:

(i) Its determination that the circumstances described at paragraph (b)(1) of this section exist; and

(ii) The impact of the circumstances described in paragraph (b)(1) of this section upon scoring methodology for affected ASM participants in a form and manner determined by CMS.

(c) Impact on final scores. (1) Except as described in paragraph (c)(2) of this section, an ASM participant who CMS identified as having been affected by a circumstance described in paragraphs (a) or (b) of this section is exempt from meeting data submission requirements identified at § 512.720 and does not receive a final score, resulting in a neutral payment adjustment for the corresponding ASM payment year.

(2) In the event that an ASM participant who CMS identified as having been affected by a circumstance described in paragraph (a) or (b) of this section submits data in accordance with the data submission requirements at § 512.720, CMS assigns the ASM participant a final score using the methodology described at § 512.745 for the applicable ASM performance year.