Overview
Measure Overview
Elevated low density lipoprotein cholesterol (LDL-C) levels contribute to clinical atherosclerotic cardiovascular disease (ASCVD) and once identified can be addressed via lipid management. Studies support that LCDL-C lowering produces marked reduction in clinical ASCVD and that lower is better for LDL-C. There are currently no similar existing measures in use in CMS programs, as previous lipid monitoring measures were identified as topped-out with recent quality measurement focusing on statin therapy and management. Following the retirement of national lipid monitoring measures, a gap in care was identified using both AHA registry data and US Veterans data. In 2022, the AHA implemented two measures addressing lipid monitoring and management in their Get With The Guidelines – Outpace™ registry (Outpace), which supports a continued gap for both lipid monitoring and management. Measurement was beneficial to address the existing gap in lipid monitoring for patients with ASCVD and LDL-C management.
CMS is considering adding this measure to the MIPS quality measure set as a new clinical quality measure. This outcome measure promotes care for adult patients with clinical atherosclerotic cardiovascular disease, ensuring patients diagnosed with this condition are tested for LDL-C and achieve an outcome of less than 70mg/dL. MIPS does not have any related measures that examine this outcome. This measure aligns with the CMS Meaningful Measures 2.0 framework and fits into priorities around chronic conditions. This measure has the potential to be in the primary care MIPS Value Pathway (MVP).
New measure never reviewed by MAP Workgroup, or PRMR or used in a Medicare program
Never submitted
N/A
Measure Specification
1) Patients aged 18 years and older with clinical Atherosclerotic Cardiovascular (ASCVD) who had a low density lipoprotein cholesterol (LDL-C) tested via a lipid panel.
2) Patients aged 18 years and older with clinical ASCVD and had a lipid panel completed during the 12-month measurement period who achieved an LDL-C of <70 mg/dL on the most recent test during the 12-month measurement period.
Not applicable
Not applicable
1) All patients aged 18 years and older diagnosed with clinical Atherosclerotic Cardiovascular (ASCVD); 2) All patients aged 18 years and older with clinical ASCVD who had a low density lipoprotein cholesterol (LDL-C) tested via a lipid panel during the measurement period.
Documentation of patient refusal of a lipid panel test during the 12-month measurement period:
Medical Reason: Documentation of medical reason(s) for not managing lipid levels (i.e., history of drug-to-drug interactions, drug intolerance or allergy to both statin and PCSK9 lipid lowering therapies, patient planning to become pregnant).
Patient Reason: Documentation of patient reason(s) for not managing lipid levels (i.e., patient unable to afford medications, patient refusal or non-compliance).
Pregnancy; ESRD; hospice; over age 66+ with advanced illness, frailty, or dementia medications.
- Digital-Administrative systems: Administrative Data (non-claims)
- Digital-Clinical Registries; Digital-Electronic Health Record (EHR) Data
- Digital-Laboratory Systems Data
Meaningfulness
Importance
As referenced in the literature review provided by the developer, there is a need for measures focusing on LDL-C monitoring. There are currently no similar existing measures in use in CMS programs, as previous lipid monitoring measures were identified as topped-out with recent quality measurement focusing on statin therapy and management. The developer cites evidence from peer-reviewed studies showing that this new measure could provide an opportunity to address disparities in care, as women have a lower likelihood of attaining LDL-C goals than men. The evidence also identified differences in treatment and outcomes based on race and sex. The measure aligns with CMS health priorities and patient goals to achieve an LDL-C of <70mg/dL. Further, the National Lipid Association has strongly advocated for the measurement and monitoring of lipids to address public health needs. Patient feedback during development strongly supported the use of the measure to drive improvement.
Conformance
This measure intends to estimate the percentage of patients diagnosed with ASCVD who undergo an LDL-C test via lipid panel and achieve an LDL-C of <70mg/dL on the most recent test. The measure numerator, denominator, and exclusions for the measure scores are defined and support the intent of the measure. This measure is reported as two performance rates: 1) percentage of patients aged 18 years and older with clinical ASCVD who received an LDL-C test via lipid panel and 2) percentage of patients who received an LDL-C test via lipid panel and achieved an LDL-C of <70mg/dL on the most recent test during the measurement period. The measure aligns with MIPS objectives to 1) improve beneficiary health through prevention, as heart disease remains the leading cause of mortality in the United States; 2) educate, engage, and empower patients as members of their care team; and 3) provide accurate, timely, and actionable performance data to clinicians, patients, and other stakeholders.
Feasibility
No, not an eCQM
Data elements for this measure are routinely collected in EHRs, claims data, clinical registries, and digital lab systems data. The measure can be implemented without significant workflow changes. The submission materials did not identify any major technical barriers associated with this measure.
Considerations for the committee: Committee members should reflect on professional and patient experiences and consider additional feasibility challenges and facilitators for this measure within the MIPS measured entity population across facilities, including rural settings.
Validity
Empiric and Face Validity [MERIT Submission Form]
Clinician - Individual
Yes
The developer established the face validity of this measure by asking members of the technical expert panel (TEP) if the measure—including both score 1 and 2 as outlined in the specification—was meaningful. Out of the 24 members, 19 agreed that the measure was meaningful and addressed an important clinical gap. The submission form did not provide information on any concerns voiced by the five members who did not agree that the measure was meaningful.
For the monitoring measure rate (score 1), the developer conducted empiric validity testing among a sample of 243 clinicians by analyzing the correlation of performance scores between the new monitoring measure rate and MIPS measure Preventive Care and Screening: Body Mass Index (BMI) Screening and Follow-Up Plan. When correlating each clinician’s measure performance, the developer found a correlation coefficient (r) of 0.577. The results indicate a moderate positive correlation between the two measures, demonstrating the empiric validity of the new monitoring measure rate as a meaningful assessment of quality of care.
For the management measure rate (score 2), the developer conducted empiric validity testing among a sample of 155 clinicians by analyzing the correlation of performance scores between the new management measure rate and MIPS measure Hemoglobin A1c (HbA1c) Poor Control (>9%). When correlating each clinician’s measure performance, the developer found a correlation coefficient (r) of 0.568. The results indicate a moderate positive correlation between the two measures, demonstrating the empiric validity of the new management measure rate as a meaningful assessment of quality of care.
This measure is submitted for use at the individual and group clinician level but lacks validation at the clinician-group level based on submission materials. The developer may wish to expand testing of this measure to improve the scientific acceptability of this measure for use in MIPS.
The measure is not risk adjusted, nor is it recommended for stratification; however, the lack of risk adjustment is addressed through denominator exclusions such as pregnancy; end-stage renal disease (ESRD); hospice; patients over the age of 66 with advanced illness, with frailty, or who are on dementia medications.
Considerations for the committee: Based on professional and patient experiences, committee members should reflect on if the face validity and moderate correlations demonstrated during empiric validity testing are sufficient evidence that this measure has the required scientific rigor for inclusion in a pay-for-performance program. Are the selected comparison measures appropriate for validating each measure score? Are any threats to validity not accounted for through exclusion that would impact payment to participating clinicians?
Reliability
Signal-to-noise [MERIT Submission Form]
Individual Clinician
The developer conducted reliability testing at the national provider identifier (NPI) level across four health systems using data gathered between January 1, 2024, and December 31, 2024, selected to maximize sample diversity and data completeness given available data and sampling constraints.
In the LDL-C monitoring group (measure score 1), 286 NPIs were evaluated with a mean reliability score of 0.833; 87.1% had scores above the 0.6 threshold, indicating strong performance differentiation. In the LDL-C management group (measure score 2), 215 NPIs were assessed with a mean reliability of 0.759, and 72.1% exceeded the 0.6 threshold, supporting the measure’s ability to reflect true variation across individual clinicians.
In response to an inquiry about availability of group-level reliability testing during evaluation for this PA, the developer shared that formal comparison of reliability between health systems is not feasible at this time due to the small number of systems during testing, which limits statistical power and precision. The developer noted that NPI-level reliability provides a conservative estimate, as aggregation typically reduces random variation and increases reliability, supporting the measure’s scientific acceptability for both individual and group clinician use. For this evaluation, this measure may be considered “met” for individual clinician level while further examination of group-level reliability is needed.
Considerations for the committee: As the measure submission indicates that this measure is specified for use at the individual and group clinician level, committee members should consider if individual clinician-level reliability testing only provides a sufficient level of scientific acceptability.
No additional analyses were conducted.
Usability
No, the submission materials do not discuss the measure’s usability within MIPS.
The developer did not include information on potential barriers or facilitators to use within MIPS. The developer noted that during a public comment period, an individual raised a concern about how combining the concepts within one measure with two scores may result in masking variations in care delivery because LDL-C testing (score 1) and patient goal attainment (monitoring rate 2) reflect different processes and might be influenced by distinct factors. The developer added they will monitor whether requiring an annual assessment may lead to overuse of LDL testing.
During collaboration on this assessment, the developer noted that the prior Physician Quality Reporting System (PQRS) utilized similar concepts, demonstrating the usability of the measures in accountability programs. The American Heart Association’s (AHA’s) Outpace Registry adopted the measure concepts in 2022. Over the course of implementation, patient- and encounter-level testing conducted by engaged facilities and their users, AHA staff, and registry vendor has found the measure to be meaningful.
Additionally, the 2025 American College of Cardiology (ACC)/AHA Clinical Performance and Quality Measures for Patients with Chronic Coronary Disease (CCD) encourages the use of lipid measurement in patients with CCD as an accountability or performance metric. In 2023, Ballantyne, et al. encouraged the re-establishment of LDL-C measurement and control as a quality metric for the U.S. health care system. These examples demonstrate the measure’s usability in different contexts.
Considerations for the committee: Based on professional and patient experiences, committee members should reflect on potential barriers or facilitators to use of this measure among MIPS clinicians.
Appropriateness of Scale
Overview
None identified
The measure developer did not provide information on the balance, potential burden, or value it could bring to the target patient populations or MIPS-participating clinicians.
Considerations for the committee:
- How might different populations see different benefits or burdens from use?
- Will the measure have the same impact in rural or low-resource settings?
- Is the measure more appropriate for some care settings versus others within MIPS?
Time to Value Realization
Overview
None specified
While the developer briefly mentions potential outcomes for measuring and monitoring LDL-C on specific patient populations in the literature review, there is a need for further examination of near- and long-term impacts of this measure after implementation across clinician and patient populations.
Considerations for the committee:
- What are the potential near- and long-term impacts of this measure on measured entities, proposed CMS program, and patient populations?
- Will benefits and burdens associated with this measure be realized within an appropriate implementation time frame?
- How will this measure mature through revisions in the future if added to the MIPS measure set?
Public Comments
Support LDL-C Monitoring and Management
See attached comment. Thank you
Heart disease accounts for…
Heart disease accounts for significant mortality and morbidity of the American population One of the major contributors to that risk is LDL cholesterol, thus
monitoring the LDL is critical and must be a quality measure.
Conditional Support for LDL-C
The AAFP recognizes the clinical importance of LDL-C monitoring and management for patients with atherosclerotic cardiovascular disease (ASCVD). The proposed quality measure is meaningful and aligns with current guidelines, but its implementation in Medicare payment programs, particularly MIPS, requires careful consideration of feasibility, equity, and clinical realities. The measure should recognize the complexity of lipid management and avoid penalizing clinicians when patients face barriers beyond their control. For the reasons outlined below, we extend conditional support for the inclusion of this measure in MIPS.
The measure is meaningful and has the potential to improve clinical outcomes for patients with ASCVD.
2. Appropriateness of Scale
3. Feasibility and Implementation
4. Time to Value Realization
5. Recommendations for CMS
Conclusion
We appreciate the opportunity to provide the important family physician perspective on this and other measures under consideration. The AAFP supports the use of the LDL-C Monitoring and Management quality measure within the Medicare MIPS program, with the above recommendations to ensure meaningful, feasible, and equitable implementation. The measure is meaningful and has the potential to improve clinical outcomes for patients with ASCVD. Ongoing evaluation and support will be essential to maximize the measure’s positive impact on patient care.
AGS Comment on LDL-C Monitoring and Management
The American Geriatrics Society (AGS) agrees with the goal of lowering low-density lipoprotein cholesterol levels for secondary prevention. However, we are concerned that the measure specifications of MUC-2025-034 for Low Density Lipoprotein Cholesterol (LDL-C) Monitoring and Management are overbroad and implementation would be challenging. We recommend improving the specifications for feasibility before the measure is adopted into the Merit-based Incentive Payment System.
Advocate Health Comments on MUC 2025- 034
Advocate Health appreciates the opportunity to provide feedback on MUC 2025-034, the Low Density Lipoprotein (LDL-C) Cholesterol measure. We recommend changing the name of the measure to align with the measure’s intent, a measure to test LDL. We also recommend CMS implement a testing measure before considering adding a control measure to align with clinical guidelines.
ABC Comments on LDL-C Monitoring and Management
Please see the attached letter from the Association of Black Cardiologists. Thank you for the opportunity to comment.
Public Comment in Support of MUC2025-034
Please see attachment. Thank you for the opportunity to submit a comment.
Support for Adding LDL-C Outcome Measure
WomenHeart: The National Coalition for Women with Heart Disease strongly supports CMS’s consideration of adding this LDL-C outcome measure to the MIPS quality measure set. From a women’s heart health perspective, this measure addresses a critical and persistent gap in cardiovascular care that disproportionately affects women.
Heart disease remains the leading cause of death for women in the United States, yet women with atherosclerotic cardiovascular disease (ASCVD) are less likely than men to be appropriately monitored, treated, and managed to evidence-based targets. Despite clear clinical evidence that lower LDL-C levels significantly reduce cardiovascular events, women are less likely to receive lipid testing, less likely to be prescribed statins or other lipid-lowering therapies, and more likely to be undertreated even after a cardiovascular event. As a result, women experience worse outcomes, including higher rates of recurrent events and mortality.
The absence of a national lipid monitoring and LDL-C outcome measure following the retirement of prior measures has contributed to missed opportunities for timely diagnosis and treatment escalation—particularly for women, who are already at increased risk of delayed or suboptimal care. The data cited from the American Heart Association registries and U.S. Veterans Health Administration appropriately identify a continued gap in lipid monitoring and management, reinforcing the need for renewed accountability in this area.
Importantly, this proposed measure shifts the focus from process alone to meaningful outcomes by ensuring that patients with ASCVD not only receive LDL-C testing but also achieve an LDL-C level below 70 mg/dL, consistent with current clinical guidelines. This outcome-based approach is especially critical for women, whose cardiovascular risk is often underestimated and whose symptoms and disease progression may differ from men.
WomenHeart also supports the alignment of this measure with the CMS Meaningful Measures 2.0 framework and chronic disease priorities, as well as its potential inclusion in a primary care MIPS Value Pathway. Primary care settings play a pivotal role in the long-term management of women with ASCVD, and this measure can help drive earlier intervention, treatment optimization, and shared decision-making.
In summary, adopting this LDL-C outcome measure would promote equitable, guideline-based cardiovascular care and help reduce persistent gender disparities in heart disease outcomes. WomenHeart urges CMS to move forward with inclusion of this measure to improve lipid management, accountability, and ultimately cardiovascular outcomes for women living with ASCVD.
PACH LDL-C Monitoring and Management Quality Measure Comment
Please find PACH's comment letter attached. Thank you for the opportunity to comment.
See attached comments.
See attached comments.
PACH LDL-C Monitoring and Management Quality Measure Comment
Please see PACH's letter attached. We appreciate the opportunity to comment on this matter.
Support for LDC-C Monitoring and and Management (MUC2025-034)
The Coalition for Kidney Health (C4KH) thanks the Agency for the opportunity to submit comments on the 2026 Measures Under Consideration List. The Coalition is writing in support of the measure, Low Density Lipoprotein Cholesterol (LDL-C) Monitoring and Management (MUC2025-034) being considered for the Merit-based Incentive Payment System. People with CKD are at high risk for atherosclerotic cardiovascular disease (ASCVD), which contributes to high morbidity and mortality for people with CKD. Despite guideline recommendations targeted at reducing cardiovascular risk in people with CKD, gaps in care persist that are particularly pernicious because CKD often goes undiagnosed, even when cardiovascular disease is present.
The Coalition for Kidney Health is a multi-stakeholder group of partners committed to public policies that advance early detection and treatment of chronic kidney disease (CKD). CKD, the progressive loss of kidney function over time, is common and burdensome. Overall, more than 1 in 3 Americans is at risk for kidney disease and more than 1 in 7 Americans have kidney disease.[1] CKD is more common in people with risk factors such as diabetes, hypertension, heart disease, and obesity, as well as in the elderly.[2] CKD can also be caused by inherited conditions like polycystic kidney disease (PKD), glomerular diseases, and autoimmune conditions like lupus, among other conditions and circumstances.[3] Many of these conditions are rare diseases, further complicating efforts for patients to secure diagnoses and access to care, but in total they drive a significant share of the burden caused by CKD (e.g., glomerulonephritis is mostly caused by rare diseases but in total accounts for 10–15 percent of kidney failure[4]). CKD is closely related to a range of comorbidities, especially to cardiovascular disease, which lead to high morbidity and mortality.[5]
People with CKD are more likely to die of cardiovascular disease than progress to kidney failure.[6] ASCVD is highly enriched in populations with CKD and is a leading cause of CVD mortality in people
with CKD, along with sudden cardiac death and heart failure. Importantly, LDL is a causal and modifiable risk factor for ASCVD. As a result, the global guideline development organization Kidney Disease Improving Global Outcomes (KDIGO) recommends measuring a lipid profile including LDL-C in all adults with CKD and lipid lowering therapy for adults fifty and older with CKD and adults between 18 and 49 under certain circumstances. The numerator of the measure under consideration is patients aged 18 and older with ASCVD who had an LDL-C test via lipid panel and patients aged 18 and older with clinical ASCVD and had a lipid panel completed during the 12-month measurement period who achieved an LDL-C for <70 mg/dL on the most recent test during the measurement period. While neither KDIGO nor the American Heart Association/American College of Cardiology sets specific LDL targets, we believe it is broadly appropriate for quality programs to encourage LDL-C monitoring and management given the prevalence of kidney disease across our health system and the context that CKD patients have a high absolute risk for ASCVD and lipid lowering therapy reduces cardiovascular events regardless of starting LDL.
The C4KH thanks CMS for its consideration of these comments. Should there be questions or comments on this submission, please contact Miriam Godwin at [email protected].
Sincerely,
The Coalition for Kidney Health
[1] Ibid.
[2] https://www.kidney.org/kidney-topics/chronic-kidney-disease-ckd
[3] Ibid.
[4] https://www.ncbi.nlm.nih.gov/books/NBK560644/
[5] https://usrds-adr.niddk.nih.gov/2023/chronic-kidney-disease/3-morbidity…
[6] Dalrymple LS, Katz R, Kestenbaum B, Shlipak MG, Sarnak MJ, Stehman-Breen C, Seliger S, Siscovick D, Newman AB, Fried L. Chronic kidney disease and the risk of end-stage renal disease versus death. J Gen Intern Med. 2011 Apr;26(4):379-85. doi: 10.1007/s11606-010-1511-x. Epub 2010 Sep 19. PMID: 20853156; PMCID: PMC3055978.
MUC2025-034 LDL-C Monitoring & Mgmt
We support the reintroduction of a lipid monitoring and LDL-C goal attainment measure for patients with clinical ASCVD, given the strong evidence base for LDL-C lowering in secondary prevention and the current gap in quality performance monitoring.
We offer the following considerations to improve clinical appropriateness, feasibility, and interpretability:
• While an LDL-C target <70 mg/dL is guideline-aligned, the measure should allow for appropriate exceptions in patients with multimorbidity and those with limited life expectancy, and recognize shared decision-making.
• Barriers such as medication intolerance, affordability, and patient refusal are often not reliably captured in structured EHR data. Clear exception pathways, coding guidance, or examples would improve reliability and fairness.
• LDL-C monitoring and LDL-C goal attainment reflect distinct constructs and should be reported separately to preserve interpretability.
• Performance may reflect data availability rather than quality in multi-payer or community settings with limited lab integration. This should be considered in specifications and testing.
• The measure should clearly specify “clinical ASCVD” to avoid inclusion of subclinical findings (e.g., coronary calcium on imaging).
• Allow a ≥50% LDL-C reduction as an acceptable alternative for patients without a baseline value.
• Given known disparities in LDL-C testing and control among women and racial and ethnic minority populations, subgroup monitoring is important to avoid exacerbating inequities.
NLA Comments on LDL-C Monitoring and Management Measure
Dear PQM,
The National Lipid Association (NLA) appreciates the opportunity to submit comments in support of the proposed measure under consideration, Low-Density Lipoprotein (LDL-C) Monitoring and Management (MUC2025-034).
The NLA is a non-profit multidisciplinary medical society focused on enhancing the science and practice of lipidology and promoting optimal cardiometabolic health. The NLA is the leader in this field, having published several patient-centered recommendations for lipid management, served as a co-author of the 2018 American Heart Association/American College of Cardiology/Multisociety Guideline on the Management of Blood Cholesterol and 2023 American Heart Association/American College of Cardiology/Multisociety Guideline for the Management of Patients with Chronic Coronary Disease, and serves as the primary educator and advocate for clinical lipidology.
Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality in the U.S., with low-density lipoprotein cholesterol (LDL-C) being a major causal risk factor. There is irrefutable evidence that lowering LDL-C leads to a proportional decrease in atherosclerotic cardiovascular disease (ASCVD) risk,[1] and that LDL-C is a reliable measure and well-established biomarker of atherogenic lipoproteins.[2] As reflected in clinical practice, what is measured is managed; therefore, effective measurement and management of LDL-C is critical to improving patient outcomes, reducing healthcare costs, closing care gaps, and addressing the broader public health burden of CVD.
Despite decades of progress, the United States has experienced a concerning reversal in ASCVD trends since 2015, with age-adjusted mortality rates increasing after more than 40 years of decline. Estimated ASCVD prevalence rose from 18.3 million individuals in 2014 to approximately 24 million in 2019.[3] Evidence further indicates significant gaps in guideline-directed LDL-C measurement and management, with underserved populations disproportionately affected.[4],[5],[6] These gaps represent an important opportunity for quality improvement.
In light of this ongoing ASCVD burden, we commend the Partnership for Quality Measurement (PQM), Centers for Medicare & Medicaid Services (CMS), and the American Heart Association (AHA) for considering this important measure, which appropriately returns LDL-C measurement and management to the forefront of quality measurement. This proposed Merit-based Incentive Payment System (MIPS) measure would assess two critical elements among patients with clinical ASCVD: (1) whether an LDL-C test was performed as part of a lipid panel, and (2) whether the patient achieved an LDL-C level of <70 mg/dL within the prior 12 months. These dual components appropriately incentivize evidence-based screening while recognizing successful LDL-C management in the highest-risk populations. Research has consistently demonstrated that many ASCVD patients do not receive appropriate lipid testing or treatment intensification,[7] underscoring the value of this measure.
While the eligible population is limited to patients with established ASCVD, the NLA recognizes this measure as an important first step in re-establishing LDL-C measurement and management in primary and secondary prevention within CMS quality programs. We encourage CMS to continue aligning future quality measures with contemporary clinical guidelines from leading U.S. organizations, including NLA and AHA, which recommend universal lipid screening for children between the ages of 9 and 11, again between 17 and 20, and for healthy adults over the age of 20 at least once every five years.[8] We also encourage consideration of LDL-C measurement and management as part of the CMS Universal Foundation of measures.
The NLA and its members strongly support inclusion of this measure in MIPS and appreciate the opportunity to provide feedback. We stand ready to support CMS in its continued efforts to reduce the burden of cardiovascular disease through improved LDL-C measurement and management.
Please do not hesitate to contact Brian Hart, Executive Director, at [email protected] or (904) 309-6222 if you have any questions.
Sincerely,
Kaye-Eileen Willard, MD, FNLA, President, National Lipid Association
Brian Hart, JD, Executive Director, National Lipid Association
[1] Expert Dyslipidemia Panel of the International Atherosclerosis Society Panel members. An International Atherosclerosis Society Position Paper: global recommendations for the management of dyslipidemia--full report. J Clin Lipidol. 2014 Jan-Feb;8(1):29-60. doi: 10.1016/j.jacl.2013.12.005. Epub 2013 Dec 17. PMID: 24528685.
[2] Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/ APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139:e1082e.
[3] Gu J, Sanchez R, Chauhan A, Fazio S, Wong N. Lipid treatment status and goal attainment among patients with atherosclerotic cardiovascular disease in the United States: A 2019 update. Am J Prev Cardiol. 2022 Mar 20;10:100336. doi: 10.1016/j.ajpc.2022.100336. PMID: 35368909; PMCID: PMC8968014.
[4] Colantonio LD, Wang Z, Jones J, et al. Low density lipoprotein cholesterol testing following myocardial infarction hospitalization among medicare beneficiaries. JACC: Adv. 2024;3:100753.
[5] Bucholz EM, Rodday AM, Kolor K, Khoury MJ, de Ferranti SD. Prevalence and Predictors of Cholesterol Screening, Awareness, and Statin Treatment Among US Adults With Familial Hypercholesterolemia or Other Forms of Severe Dyslipidemia (1999-2014). Circulation. 2018;137(21):2218-2230. doi:10.1161/CIRCULATIONAHA.117.032321.
[6] Nanna MG, Wang TY, Xiang Q, Goldberg AC, Robinson JG, Roger VL, Virani SS, Wilson PWF, Louie MJ, Koren A, Li Z, Peterson ED, Navar AM. Sex Differences in the Use of Statins in Community Practice. Circ Cardiovasc Qual Outcomes. 2019 Aug;12(8):e005562. doi: 10.1161/CIRCOUTCOMES.118.005562. Epub 2019 Aug 16. PMID: 31416347; PMCID: PMC6903404.
[7] Colantonio LD, Wang Z, Jones J, et al. Low density lipoprotein cholesterol testing following myocardial infarction hospitalization among medicare beneficiaries. JACC: Adv. 2024;3:100753.
[8] Grundy SM, Stone NJ, Bailey AL, Beam C, Birtcher KK, Blumenthal RS, Braun LT, de Ferranti S, Faiella-Tommasino J, Forman DE, Goldberg R, Heidenreich PA, Hlatky MA, Jones DW, Lloyd-Jones D, Lopez-Pajares N, Ndumele CE, Orringer CE, Peralta CA, Saseen JJ, Smith SC Jr, Sperling L, Virani SS, Yeboah J. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/ APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;139:e1082e.
Letter Supporting Improved LDL-C Quality Measurement
Letter Supporting Improved LDL-C Quality Measurement
Support for the proposed LDL-C Monitoring and Management Measure
The Family Heart Foundation is a non-profit patient advocacy organization whose mission is to save generations of families from heart disease through timely identification and improved care of familial hypercholesterolemia and elevated lipoprotein(a). We strongly support the proposed LDL-C measure as a means of improving outcomes for patients by correcting the disconnect which exists between the existing statin-based quality measure, current national cholesterol treatment guidelines, and actual control of LDL-C in high-risk individuals, such as those with atherosclerotic cardiovascular disease (ASCVD).
The Foundation maintains a large proprietary database called the Family Heart Database which contains US medical claims of medication use, diagnoses, procedures and/or surgeries in >340 million individuals between 2012–2023, representing more than half of the national census population annually, with corresponding laboratory (primarily lipid) data available in approximately one-third-of these individuals. We recently performed an analysis examining the state of control of LDL-C in over 3M individuals with ASCVD by payer type during 2023 which was presented as a poster at the Academy of Managed Care Nexus meeting in October 2025. A copy of the poster is attached.
For Medicare patients, only 36% of people with ASCVD in this analysis achieved an LDL-C <70mg/dL and for those with commercial insurance, that figure was just 30%. We also examined rates of control of LDL-C for the top 10 Medicare and Commercial plans by volume of ASCVD patients and the top performing plan was United Healthcare/AARP where only 40.1% of plan members with ASCVD in this analysis achieved an LDL-C < 70mg/dL.
In a separate analysis which was published in December 2025 in the American Journal of Preventive Cardiology (https://www.sciencedirect.com/science/article/pii/S2666667725004295), we demonstrated similar results but also found that women and Black individuals were significantly less likely to achieve an LDL-C of < 70 mg/dL, suggesting significant disparities in care.
This data on actual control of LDL-C in people with ASCVD stands in contrast to the 2023 performance data on the current statin-based quality measure, which was recently published by NCQA (https://www.ncqa.org/report-cards/health-plans/state-of-health-care-qua…). In this dataset, 82% of commercial patients and 85-86% of Medicare patients (all with ASCVD) achieved the statin performance measure: "Received Statin Therapy. Members who were dispensed at least one high- or moderate-intensity statin medication". Taken together, this indicates a significant disconnect between the current statin-based performance measure and actual control of LDL-cholesterol in ASCVD patients.
The current statin-based measure is based on the 2013 ACC/AHA Cholesterol Guidelines which eliminated LDL-C treatment goals. However, the 2018 ACC/AHA Multi-Society Cholesterol guidelines re-introduced the concept of an LDL-C "threshold" of >70 mg/dL in patients with ASCVD, above which clinicians are encouraged the intensify therapy. This approach of recommending a threshold above which therapy should be intensified was maintained and extended in the 2022 ACC Non-Statin Expert Consensus Decision Pathway. Performance measures, which exist to assess quality of care delivered, should be aligned with the national treatment guidelines and at present, that is not the case. Adoption of the proposed measure would address that issue.
Finally, statins, ezetimibe, PCSK9 inhibitors, and bempedoic acid have all been shown to not only lower LDL-C but to also significantly reduce cardiovascular morbidity and mortality in high-risk individuals. This was not the case in 2015 when the statin-based measure was adopted. LDL-cholesterol should be the target of therapy and performance should be assessed by the percentage of individuals with ASCVD who achieve a goal of LDL-C <70 mg/dL. The Family Heart Foundation urges CMS to adopt the proposed measure.
Merck Comments Re MUC2025-034
MUC2025-034: Low-Density Lipoprotein Cholesterol (LDL-C) Monitoring and Management (MIPS)
Merck is highly supportive of the proposed “Low-Density Lipoprotein Cholesterol (LDL-C) Monitoring and Management” measure (MUC2025-034) and commends CMS for advancing evidence-based atherosclerotic cardiovascular disease (ASCVD) care. ASCVD remains the leading cause of death in the United States, driving significant morbidity, mortality, and health care costs.[1] This measure fills a critical gap in current CMS quality metrics, which have historically focused on statin prescribing and adherence rather than on monitoring and achieving guideline-directed LDL-C targets.[2] Elevating LDL-C monitoring and management has the potential to catalyze better outcomes for patients as care teams confirm treatment effectiveness and intensify therapy when needed to achieve LDL-C targets.
The measure appropriately aligns with American College of Cardiology/American Heart Association (ACC/AHA) cholesterol management guidelines that emphasize LDL-C reduction to lower ASCVD risk.[3] Robust evidence has demonstrated LDL-C is a modifiable, causal risk factor for ASCVD[4] and LDL-C reductions lead to proportional reductions in major cardiovascular events.[5] Despite this, persistent gaps in real-world practice exist. Among Medicare beneficiaries, only about 30% receive LDL-C testing within 90 days following myocardial infarction,[6] even though timely LDL-C measurement and control are associated with improved survival and better adherence to therapy.[7] The measure steward’s validity and reliability testing using their Get With The Guidelines – Outpace™ registry also indicate there is meaningful room for improvement, with mean performance for monitoring at 46.8% (range 30% - 100%) and management at 64.9% (range 18.2% - 85.7%). These data underscore both the need and opportunity for a national measure to raise performance across diverse settings.
To enhance the measure’s clinical relevance and population-health impact, Merck recommends CMS consider exploring risk-based stratification for the measure. The current measure specifications support treating to an LDL-C target of <70mg/dL for those with clinical ASCVD. The 2022 ACC Expert Consensus Decision Pathway supports an LDL-C target of <70mg/dL for those with clinical ASCVD who are considered not at very high-risk; however, an LDL-C target of <55mg/dL is recommended for those at very high-risk for future events.3,[8] Clinical practice guidelines define very high-risk for future events as either two or more major ASCVD events or one major ASCVD event and multiple high-risk conditions. One study estimated about 82% of U.S. adults with ASCVD fall within the very-high ASCVD risk category.[9] Exploring stratified performance reporting for those at very-high-risk with an LDL-C target of <55 mg/dL could identify gaps and guide targeted quality improvement efforts that could affect the majority of U.S. adults currently living with ASCVD.
Overall, Merck urges CMS to implement the “LDL-C Monitoring and Management” measure in the Merit-based Incentive Payment System (MIPS) program. In addition, Merck recommends CMS consider enhancements to the measure by exploring risk-based stratification for the very high-risk clinical ASCVD population with an LDL-C target of <55mg/dL.
References
[1] Virani SS, Alonso A, Aparicio HJ, et al. Heart disease and stroke statistics—2021 update: a report from the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-743.
[2] Virani SS, Aspry K, Dixon DL, et al. The importance of low-density lipoprotein cholesterol measurement and control as performance measures: a joint clinical perspective from the National Lipid Association and the American Society for Preventive Cardiology. Am J Prev Cardiol. 2023;13:100472. doi:10.1016/j.ajpc.2023.100472
[3] Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2019;73(24):e285-e350. doi:10.1016/j.jacc.2018.11.003
[4] Ference BA, Ginsberg HN, Graham I, et al. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017 Aug 21;38(32):2459-72.
[5] Baigent C, Blackwell L, Emberson J, et al. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 8;376(9753):1670-81.
[6] Colantonio LD, Wang Z, Jones J, et al. Low-density lipoprotein cholesterol testing following myocardial infarction hospitalization among Medicare beneficiaries. JACC Adv. 2023;3(1):100753. doi:10.1016/j.jacadv.2023.100753
[7] Solomon MD, Leong TK, Levin E, et al. Cumulative adherence to secondary prevention guidelines and mortality after acute myocardial infarction. J Am Heart Assoc. 2020;9(6):e014415. doi:10.1161/JAHA.119.014415
[8] Writing Committee, Lloyd-Jones DM, Morris PB, et al. 2022 ACC expert consensus decision pathway on the role of nonstatin therapies for LDL-cholesterol lowering in the management of atherosclerotic cardiovascular disease risk: a report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2022 Oct 4;80(14):1366-418.
[9] Alanaeme CJ, Bittner V, Brown TM, et al. Estimated number and percentage of US adults with atherosclerotic cardiovascular disease recommended add‑on lipid‑lowering therapy by the 2018 AHA/ACC multi‑society cholesterol guideline. Am Heart J Plus: Cardiol Res Pract. 2022;21:100201. doi:10.1016/j.ahjo.2022.100201
2025 MUC List comments
Please see the attached letter for our comments on the LDL-C Monitoring and Management (MUC2025-034) measure.
Support LDL-C Monitoring and Management Measure
Esperion Therapeutics, Inc. strongly support the implementation of the measure under consideration for Low-density Lipoprotein Cholesterol (LDL-C) Monitoring and Management.
We commend CMS for recognizing the importance of effectively managing LDL-C, a major risk factor for cardiovascular disease (CVD), the leading cause of morbidity and mortality in the United States (US) and worldwide. By 2050, over 180 million people in the US are predicted to have CVD, and the associated health care costs are projected to quadruple. The effective management of LDL-C will result in improved health care outcomes for patients and substantial cost savings for the US.
High cholesterol is a silent killer with no obvious symptoms, and as such, patients and clinicians may deprioritize managing it, especially when other comorbidities exist; medication adherence and long-term persistence is a known challenge. This proposed measure will incentivize clinicians to pay more attention to lipid management in their most high CV risk patients. The measure appropriately puts the focus on achievement of an LDL-C target <70 mg/dL, and allows the treatment approach to be driven by evidence-based guidelines and clinician-patient shared decision-making.
With the implementation of this proposed measure, we recommend that CMS retire the current measure “Statin Therapy for the Prevention and Treatment of Cardiovascular Disease” (Quality Number #438). Statins are the foundation of lipid-lowering therapy and CV risk reduction, but real-world evidence has consistently demonstrated that most high-risk patients are not at goal LDL-C: either because they not receiving adequate statin therapy or are not intensifying lipid-lowering therapy. The current measure only calculates the proportion of patients prescribed or receiving a prescription for a statin during the measurement period. As such, the measure may overestimate actual statin consumption, as well as exclude patients who may be statin intolerant and taking non-statin lipid-lowering therapies – in both cases, leading to an incomplete picture of the quality of care for patients at high CV risk.
Esperion works tirelessly to deliver innovative medicines that help people reach their goals today, tomorrow, and well into the future. The patient is at the center of every decision we make, and we are committed to improving those lives we serve. We strongly believe that this new measure will reflect a more complete picture of the quality of lipid management, and is a timely and needed change in order to stem rising CVD event rates and mortality.
Thank you for the opportunity to provide comments.
Sincerely,
LeAnne Bloedon, MS, RD
Vice President, Head of Development
LDL-C Monitoring and Management
Thank you for the opportunity to comment. Please see the attached letter in support of the ratification of this quality measure, submitted by PCNA.
Low-Density Lipoprotein Cholesterol Monitoring and Management
Please see the attachment. We appreciate the opportunity to provide comment.
NKF Comments on LDL-C Monitoring and Management Measure
NKF supports the LDL-C Monitoring and Management measure within the Merit-based Incentive Payment System (MIPS) and recognizes its importance given the high cardiovascular risk among patients with chronic kidney disease and ESRD. Monitoring and appropriate management of LDL-C is consistent with established clinical guidelines and has the potential to improve long-term cardiovascular outcomes.
NKF encourages PQM to share our comment with the clinician committee that is reviewing the measure and ask the measure steward (American Heart) to clarify why kidney disease has been excluded. Given the complex care environments in which kidney patients receive treatment, alignment with nephrology practice norms will be essential to ensure the measure promotes appropriate care without creating undue reporting burden or penalizing clinicians caring for medically complex patients.
MUC2025-034 Measure
Support
Low Density Lipoprotein Cholesterol (LDL-C) Monitoring and Mgt
Please see attachment. Thank you for the opportunity to submit a comment.
Low-Density Lipoprotein Cholesterol (LDL-C) Monitoring and Manag
Ladies and Gentlemen:
The National Forum for Heart Disease & Stroke Prevention strongly supports the implementation of the proposed measure regarding Low-Density Lipoprotein Cholesterol (LDL-C) monitoring and management for patients with Atherosclerotic Cardiovascular Disease (ASCVD).
The National Forum is a nonpartisan, nonprofit organization that leads collaborative action to ensure optimal cardiovascular and metabolic health and well-being for all people throughout their lifespans. National Forum members include more than 100 clinical, patient, and public health organizations, agencies, companies, and institutions.
Alignment with Contemporary Guidelines
Heart disease remains the leading cause of death in the United States[i], and elevated LDL‑C is a major contributor to ASCVD. From 1999-2002 to 2015-2018, cholesterol control in the United States increased significantly. However, this progress stalled in the mid-2010s[ii], following the retirement of key quality measures that once supported the detection and treatment of hypercholesterolemia.
Lowering LDL‑C is one of the most effective ways to prevent repeat heart attacks and strokes[iii]. Numerous studies have found that reducing LDL‑C lowers the risk of future cardiovascular events. Clinical guidelines recommend screening and the appropriate use of evidence-based therapies to manage hyperlipidemia. Yet millions of high‑risk patients still are not receiving treatment that is complete or consistent with these standards.
Today, the primary quality measure, prescribing a statin, is too limited and does not fully reflect what high‑quality patient care requires. Introducing the proposed quality measure focused on LDL‑C would help enhance patient care, support medication adherence, increase patient engagement, and ultimately improve cardiovascular health.
The proposed measure aligns with the 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients with Chronic Coronary Disease[iv], which emphasizes that "lower [LDL-C] is better." By establishing a threshold of < 70 mg/dL or a > 50% reduction in LDL-C, the proposed measure provides clinicians with actionable targets to reduce clinical ASCVD events.
Furthermore, new data have emerged that support the re-establishment of monitoring LDL-C levels after initiating or modifying treatment. Observational studies have found that routine LDL-C monitoring is associated with increased adherence to treatment.[v]
Improving Quality and Fairness in Care
Adopting this measure would be a critical step toward ensuring more consistent, high‑quality care for all patients. Data indicate clear disparities in lipid control based on:
Standardized measurement ensures that quality improvement initiatives are applied fairly across these vulnerable populations.
Economic Impact and Long-Term Sustainability
The financial burden of cardiovascular care in the US is projected to reach staggering levels. By 2050, annual costs associated with cardiovascular risk factors are forecasted to triple to $1.34 trillion, while annual healthcare costs for cardiovascular conditions are projected to quadruple to $1.49 trillion. Shifting the focus toward proactive LDL-C management is not only a clinical necessity but a fiscal imperative to mitigate these rising costs and productivity losses.
Conclusion
Reintroducing a focused LDL-C management measure will bridge the current gap in ASCVD care, drive down long-term healthcare expenditures, and save lives through primary and secondary prevention. We urge CMS to adopt this measure to ensure that "lower is better" becomes the standard of care for all Medicare beneficiaries.
Respectfully yours,
John M. Clymer
Executive Director
[i] American Heart Association. Heart disease remains leading cause of death as key health risk factors . continue to rise. January 27, 2025. https://newsroom.heart.org/news/heart-disease-remains-leading-cause-of-death-as-key-health-risk-factors-continue-to-rise
[ii] Carroll MD, Fryar CD, Gwira JA, Iniguez M. Total and high-density lipoprotein cholesterol in adults: United States, August 2021–August 2023. NCHS Data Brief, no 515. Hyattsville, MD: National Center for Health Statistics. 2024. DOI: https://dx.doi.org/10.15620/cdc/165796.
[iii] Nissen SE. What We Have Learned About Reducing Low-Density Lipoprotein Cholesterol and Coronary Plaques. JAMA Cardiol. 2024;9(12):1092–1093. doi:10.1001/jamacardio.2024.3213
[iv]Virani SS, Newby LK, Arnold SV, et. al. 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. Volume 148, Number 9. https://doi.org/10.1161/CIR.0000000000001168
[v] Apple SJ, Clark R, Daich J, et al. Closing the Gaps in Care of Dyslipidemia: Revolutionizing Management with Digital Health and Innovative Care Models. Rev Cardiovasc Med. 2023;24(12):350. Published 2023 Dec 13. https://doi:10.31083/j.rcm2412350
[vi] Gavina C, Araújo F, Teixeira C, et al. Sex differences in LDL-C control in a primary care population: The PORTRAIT-DYS study. Atherosclerosis. 2023;384:117148. https://doi:10.1016/j.atherosclerosis.2023.05.017
[vii] Eagan BM, Li J, Sarasua SM, et al. Cholesterol Control Among Uninsured Adults Did Not Improve From
2001-2004 to 2009-2012 as Disparities With Both Publicly and Privately Insured Adults Doubled. Journal of the American Heart Association. https://www.ahajournals.org/doi/pdf/10.1161/jaha.117.006105
LDL Measure
This is a clinically significant measure that is going to highly impactful and is also highly consonant with latest practice guidelines. This measure is also clearly quantifiable and serves health system and patient care needs.