Comparative effectiveness of cardiac resynchronization therapy in older patients with heart failure: Systematic review and meta-analysis.

BACKGROUND: Pivotal CRT trials enrolled patients with HFrEF significantly younger than the typical contemporary patient with HFrEF. Thus, the risks and benefits in this older population with HFrEF are largely unknown. We sought to perform meta-analyses comparing safety and effectiveness of cardiac resynchronization therapy (CRT) in older vs younger patients with heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: PubMed, The Cochrane Library, Scopus, and Web of Science were queried for comparative effectiveness studies of CRT in older patients with HFrEF. Title, abstract, and full-text screening was performed to identify studies comparing at least 1 prespecified end point between older and younger adult patients with at least 50 participants. Random effects meta-analysis in the left ventricular ejection fraction (LVEF) mean difference (older minus younger) and the relative risk (RR) of death, improvement in New York Heart Association (NYHA) functional class, and complications are reported along with estimates of heterogeneity. In 7 studies, there was similar LVEF improvement between groups (mean difference 1.14, 95% confidence interval [CI] -0.04 to 2.32, P = .06, I2 = 53%). Older patients were equally likely as younger patients to see an improvement in NYHA functional class of at least 1 in 6 studies (RR 0.99, 95% CI 0.93-1.06, P = .76, I2 = 25%). No significant differences in the incidence of hematoma, pneumothorax, lead dislodgment, cardiac perforation, or infection requiring explant was observed. The RR of mortality in 11 studies demonstrated higher risk of all-cause mortality in older patients (RR 1.05, 95% CI 1.03-1.08, P < .01, I2 = 0%). CONCLUSIONS: Compared with younger patients, older patients receiving CRT were equally likely to experience improvement in LVEF, left ventricular end-diastolic diameter, and NYHA functional class. There was no difference in procedural complications. The higher rate of all-cause mortality in older patients likely reflects a greater underlying risk of death from competing causes.

Evaluation of Hospital Performance Using the Excess Days in Acute Care Measure in the Hospital Readmissions Reduction Program.

The Hospital Readmissions Reduction Program (HRRP) has penalized hospitals with higher 30-day readmission rates more than $3 billion to date. Clinicians and policy experts have raised concerns that the 30-day readmission measure used in this program provides an incomplete picture of performance because it does not capture all hospital encounters that may occur after discharge. In contrast, the excess days in acute care (EDAC) measure, which currently is not used in the HRRP, captures the full spectrum of hospital encounters (emergency department, observation stay, inpatient readmission) and their associated lengths of stay within 30 days of discharge. This study of 3173 hospitals that participated in the HRRP in fiscal year 2019 compared performance on the readmission and EDAC measures and evaluated whether using the EDAC measure would change hospitals' penalty status for 3 conditions targeted by the HRRP. Overall, only moderate agreement was found on hospital performance rankings by using the readmission and EDAC measures (weighted κ statistic: heart failure, 0.45 [95% CI, 0.42 to 0.47]; acute myocardial infarction [AMI], 0.37 [CI, 0.35 to 0.40]; and pneumonia, 0.50 [CI, 0.47 to 0.52]). Under the HRRP, the penalty status of 769 (27.0%) of 2845 hospitals for heart failure, 581 (28.3%) of 2055 for AMI, and 724 (24.9%) of 2911 for pneumonia would change if the EDAC measure were used instead of the readmission measure to evaluate performance. Fewer small and rural hospitals would receive penalties. The Centers for Medicare & Medicaid Services should consider using the EDAC measure, which provides a more comprehensive picture of postdischarge hospital use, rather than the 30-day readmission measure to evaluate health care system performance under federal quality, reporting, and value-based programs.

Inclusion of Performance Parameters and Patient Context in the Clinical Practice Guidelines for Heart Failure.

BACKGROUND: To facilitate evidence-based medicine (EBM) on an individual level, it may be important for clinical practice guidelines (CPGs) to incorporate the performance parameters of diagnostic studies and therapeutic interventions (such as likelihood ratio and absolute benefit or harm), and to incorporate relevant patient contexts that may influence decision-making. We sought to determine the extent to which heart failure CPGs currently incorporate this information. METHODS: We reviewed the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) 2013 Heart Failure CPG, the 2017 ACCF/AHA/HFSA update, and European Society of Cardiology (ESC) 2016 Heart Failure CPG. We abstracted variables for each CPG recommendation from the following domains: quality of evidence, strength of recommendation, diagnostic and therapeutic performance parameters, and patient context. RESULTS: We examined 169 recommendations from the ACCF/AHA 2013 CPGs and 2017 update and 187 recommendations from the 2016 ESC CPGs. Performance parameters for diagnostic studies (2013 ACCF/AHA: 13%; 2017 ACCF/AHA/HFSA update: 0%; 2016 ESC: 0%) and therapeutic interventions (2013 ACCF/AHA: 65%; 2017 ACCF/AHA/HFSA update: 64%; 2016 ESC: 16%) were not commonly included in CPGs. Patient context was included in about half of ACCF/AHA recommendations and a quarter of ESC recommendations. CONCLUSIONS: The majority of recommendations from heart failure CPGs lack information on diagnostic and therapeutic performance parameters and patient context. Given the importance of these components to effectively implement EBM, particularly for a heterogeneous heart failure population, innovative strategies are needed to optimize CPGs so they provide comprehensive yet succinct recommendations that can improve population-level outcomes and ensure optimal patient-centered care.

Unanswered Questions in Contemporary Heart Failure.

OBJECTIVE: The epidemiology of heart failure (HF) is changing. This study aimed to describe questions that arise during the routine care of HF patients that are unanswered by the current literature and describe how the type and focus of these questions has changed over time. METHODS: Investigators from the National Heart, Lung, and Blood Institute-sponsored Heart Failure Apprentice Network collected and categorized questions from 5 academic hospitals over 12 months. A total of 174 unanswered questions were collected and analyzed. RESULTS: Compared with 2004, there were more unanswered questions about "whether" to use therapies and fewer about "how" to use therapies. There were fewer questions about what therapeutic targets, therapy adjustment, and combination therapies. There were more questions about whether or how to stop therapies and how to add therapies back. Newly prominent topics, not observed in 2004, including novel therapeutics, refractory ventricular tachycardia, right heart failure, and nutrition/frailty, accounted for 24% of questions. CONCLUSIONS: Compared with 2004, there are fewer unanswered questions about how to use, adjust, and combine therapies. There were more unanswered questions about whether and how to stop therapies. Almost 25% of unanswered questions dealt with topics indicative of more advanced disease which were not observed in 2004.

Outpatient intravenous diuresis in a rural setting: safety, efficacy, and outcomes.

Purpose: To evaluate the safety, efficacy, and outcomes of outpatient intravenous diuresis in a rural setting and compare it to urban outcomes. Methods: A single-center study was conducted on 60 patients (131 visits) at the Dartmouth-Hitchcock Medical Center (DHMC) from 1/2021-12/2022. Demographics, visit data, and outcomes were collected and compared to urban outpatient IV centers, and inpatient HF hospitalizations from DHMC FY21 and national means. Descriptive statistics, T-tests and chi-squares were used. Results: The mean age was 70 ± 13 years, 58% were male, and 83% were NYHA III-IV. Post-diuresis, 5% had mild-moderate hypokalemia, 16% had mild worsening of renal function, and 3% had severe worsening of renal function. No hospitalizations occurred due to adverse events. The mean infusion-visit urine output was 761 ± 521 ml, and post-visit weight loss was -3.9 ± 5.0 kg. No significant differences were observed between HFpEF and HFrEF groups. 30-day readmissions were similar to urban outpatient IV centers, DHMC FY21, and the national mean (23.3% vs. 23.5% vs. 22.2% vs. 22.6%, respectively; p = 0.949). 30-day mortality was similar to urban outpatient IV centers but lower than DHMC FY21 and the national means (1.7% vs. 2.5% vs. 12.3% vs. 10.7%, respectively; p < 0.001). At 60 days, 42% of patients had ≥1 clinic revisit, 41% had ≥1 infusion revisit, 33% were readmitted to the hospital, and two deaths occurred. The clinic avoided 21 hospitalizations, resulting in estimated cost savings of $426,111. Conclusion: OP IV diuresis appears safe and effective for rural HF patients, potentially decreasing mortality rates and healthcare expenses while mitigating rural-urban disparities.

Biomarkers and cardiovascular risk assessment for primary prevention: an update.

BACKGROUND: Interest in cardiovascular biomarkers in primary prevention has increased dramatically in the past decade. This increase has been fueled by an improved understanding of cardiovascular pathophysiology, as well as novel technologies for biomarker identification. CONTENT: In this review we provide a brief overview of recent concepts in the evaluation of screening biomarkers, because biomarkers may behave differently when used for screening as opposed to diagnosis or disease staging. The following specific biomarker examples are then discussed, with a focus on data from primary prevention studies: high-sensitivity C-reactive protein, B-type natriuretic peptide, lipoprotein-associated phospholipase A2, and high-sensitivity troponin T. The article concludes by addressing novel platforms for biomarker discovery, reviewing recent examples from the field of metabolomics. SUMMARY: An ongoing challenge is to develop screening strategies that can identify individuals at risk for cardiovascular events well before symptoms appear. For this purpose, the measurement of soluble biomarkers could be an important adjunct to traditional cardiovascular risk assessment. Recent studies highlight both the strengths and limitations of "novel" circulating biomarkers, and suggest that substantial work is still needed to identify biomarkers that are sufficiently accurate and cost-effective for routine use in primary prevention.

How Do I Optimize Heart Failure Medications for Patients with Hypotension or Chronic Kidney Disease?

HF Medications for Hypotension or CKDThe cornerstone of treatment for HF with reduced ejection fraction is GDMT; however, safely delivering maximal therapy is often hampered by low blood pressure, labile renal function, or both. Reviewing the physiologic basis of GDMT and exploring each drug's mechanism of action and unique properties can enable careful initiation and titration of therapy, even in patients with hypotension or CKD.

Opposing forces of cardiogenic shock: left ventricular outflow obstruction, severe mitral regurgitation, and left ventricular dysfunction in Takotsubo cardiomyopathy.

Rates of stress (Takotsubo) cardiomyopathy have increased during the coronavirus pandemic due to social stressors, even in patients who are not infected with the virus. At times, Takotsubo cardiomyopathy (TC) may present as cardiogenic shock. Herein, we present a case during the pandemic of shock from TC secondary to left ventricular outflow tract obstruction (LVOTO), mitral regurgitation (MR), and left ventricular (LV) dysfunction. The contrasting management strategy of LVOTO, MR, and LV failure was cause for clinical challenge, and we highlight the balance of treating these opposing forces.

Coverage with evidence development: where are we now?

OBJECTIVES: CMS' coverage with evidence development (CED) policy allows Medicare beneficiaries to access promising therapies and services while additional data are collected. CED program characteristics are mostly unreported, and qualities associated with retirement of CED data collection requirements are unknown. We aimed to review and systematically describe CED program history and components and report programmatic elements correlated with retirement of CED data collection requirements, while identifying areas for policy improvement. STUDY DESIGN: Systematic review. METHODS: We extracted CED information from the CMS website, ClinicalTrials.gov, PubMed, internet searches, and communication with CMS. RESULTS: There were 27 CED determinations from 2005 to 2022 in 8 therapeutic areas, with the most for cardiovascular diseases (8/27; 30%). Duration of CED programs (range, 1-16 years) and the number of related registries and clinical trials (range, 0-34) were widely variable. Only 4 CEDs have had data collection requirements with continued National Coverage Determination (NCD); 3 relate to cardiovascular therapies, and all have some public availability of findings resulting from CED-related data collection mechanisms. There were 2 instances of NCD revocation and deferral to local coverage decisions. CONCLUSIONS: Changes in the CED program through improving program predictability and transparency with regard to outstanding questions, roles of relevant stakeholders, and requirements for reporting and reevaluation would strengthen the program's effectiveness. Ultimately, these improvements would provide incentives for stakeholder participation in data collection to achieve the goal of increasing access to beneficial therapies and improving clinical outcomes.

Complications and Mortality Following CRT-D Versus ICD Implants in Older Medicare Beneficiaries With Heart Failure.

OBJECTIVES: This study sought to assess the comparative effectiveness of cardiac resynchronization therapy with defibrillator (CRT-D) over implantable cardioverter-defibrillator (ICD) alone in older Medicare patients with heart failure with reduced ejection fraction (HFrEF). BACKGROUND: Despite growing numbers of older patients with HFrEF, the benefits of cardiac resynchronization therapy (CRT) in this group are largely unknown. METHODS: A cohort of fee-for-service Medicare beneficiaries ≥65 years of age with HFrEF and enrolled in Medicare Part D who underwent CRT-D or ICD implantation from January 2008 to August 2015 was identified. Beneficiaries were divided by age (65-74, 75-84, and 85+ years), and outcomes were compared between the CRT-D and ICD groups after inverse probability weighting. RESULTS: Compared with the ICD group, the CRT-D group was older and more likely to be White, be female, and have left bundle branch block. After weighting, overall complications were high across age and device groups (14%-20%). The 1-year mortality was high across all groups. In the 2 oldest age strata, the hazard of death was lower in the CRT-D group (HR: 0.90; 95% CI: 0.86-0.95 and HR: 0.81; 95% CI: 0.72-0.90, respectively; P < 0.001); the hazard of heart failure hospitalization was lower for CRT-D vs ICD in the 85+ years age group (HR: 0.82; 95% CI: 0.74-0.92; P < 0.001). CONCLUSIONS: In older Medicare beneficiaries undergoing ICD with or without CRT, complications and 1-year mortality were high. Compared with ICD alone, CRT-D was associated with a lower hazard of mortality in patients ≥74 years of age and lower hazard of HF hospitalization in those ≥85 years of age. These findings support the use of CRT in eligible older patients undergoing ICD implantation.

Using Consistently Low Performance to Identify Low-Quality Physician Groups.

Importance: There has been a growth in the use of performance-based payment models in the past decade, but inherently noisy and stochastic quality measures complicate the assessment of the quality of physician groups. Examining consistently low performance across multiple measures or multiple years could potentially identify a subset of low-quality physician groups. Objective: To identify low-performing physician groups based on consistently low performance after adjusting for patient characteristics across multiple measures or multiple years for 10 commonly used quality measures for diabetes and cardiovascular disease (CVD). Design, Setting, and Participants: This cross-sectional study used medical and pharmacy claims and laboratory data for enrollees ages 18 to 65 years with diabetes or CVD in an Aetna health insurance plan between 2016 and 2019. Each physician group's risk-adjusted performance for a given year was estimated using mixed-effects linear probability regression models. Performance was correlated across measures and time, and the proportion of physician groups that performed in the bottom quartile was examined across multiple measures or multiple years. Data analysis was conducted between September 2020 and May 2021. Exposures: Primary care physician groups. Main Outcomes and Measures: Performance scores of 6 quality measures for diabetes and 4 for CVD, including hemoglobin A1c (HbA1c) testing, low-density lipoprotein testing, statin use, HbA1c control, low-density lipoprotein control, and hospital-based utilization. Results: A total of 786 641 unique enrollees treated by 890 physician groups were included; 414 655 (52.7%) of the enrollees were men and the mean (SD) age was 53 (9.5) years. After adjusting for age, sex, and clinical and social risk variables, correlations among individual measures were weak (eg, performance-adjusted correlation between any statin use and LDL testing for patients with diabetes, r = -0.10) to moderate (correlation between LDL testing for diabetes and LDL testing for CVD, r = .43), but year-to-year correlations for all measures were moderate to strong. One percent or fewer of physician groups performed in the bottom quartile for all 6 diabetes measures or all 4 cardiovascular disease measures in any given year, while 14 (4.0%) to 39 groups (11.1%) were in the bottom quartile in all 4 years for any given measure other than hospital-based utilization for CVD (1.1%). Conclusions and Relevance: A subset of physician groups that was consistently low performing could be identified by considering performance measures across multiple years. Considering the consistency of group performance could contribute a novel method to identify physician groups most likely to benefit from limited resources.

Assessment of Second-Generation Diabetes Medication Initiation Among Medicare Enrollees From 2007 to 2015.

Importance: Little is known about how new and expensive drugs diffuse into practice affects health care costs. Objective: To describe the variation in second-generation diabetes drug use among Medicare enrollees between 2007 and 2015. Design, Setting, and Participants: This population-based, cross-sectional study included data from 100% of Medicare Parts A, B, and D enrollees who first received diabetes drug therapy from January 1, 2007, to December 31, 2015. Patients with type 1 diabetes were excluded. Data were analyzed beginning in the spring of 2018, and revisions were completed in 2019. Exposures: For each patient, the initial diabetes drug choice was determined; drugs were classified as first generation (ie, approved before 2000) or second generation (ie, approved after 2000, including dipeptidyl peptidase 4 [DPP-4] inhibitors, glucagon-like peptide-1 [GLP-1] receptor agonists, and sodium-glucose cotransporter-2 [SGLT-2] inhibitors). Main Outcomes and Measures: The primary outcome was the between-practice variation in use of second-generation diabetes drugs between 2007 and 2015. Practices with use rates of second-generation diabetes drugs more than 1 SD above the mean were considered high prescribing, while those with use rates more than 1 SD below the mean were considered low prescribing. Results: Among 1 182 233 patients who initiated diabetes drug therapy at 42 977 practices between 2007 and 2015, 1 104 718 (93.4%) were prescribed a first-generation drug (mean [SD] age, 75.4 [6.7] years; 627 134 [56.8%] women) and 77 515 (6.6%) were prescribed a second-generation drug (mean [SD] age, 76.5 [7.2] years; 44 697 [57.7%] women). By December 2015, 22 457 practices (52.2%) had used DPP-4 inhibitors once, compared with 3593 practices (8.4%) that had used a GLP-1 receptor agonist once. Furthermore, 17 452 practices (40.6%) were using DPP-4 inhibitors in 10% of eligible patients, while 1286 practices (3.0%) were using GLP-1 receptor agonists in 10% of eligible patients, and SGLT-2 inhibitors, available after March 2013, were used at least once by 1716 practices (4.0%) and used in 10% of eligible patients by 872 practices (2.0%) by December 2015. According to Poisson random-effect regression models, beneficiaries in high-prescribing practices were more than 3-fold more likely to receive DPP-4 inhibitors (relative risk, 3.55 [95% CI, 3.42-3.68]), 24-fold more likely to receive GLP-1 receptor agonists (relative risk, 24.06 [95% CI, 14.14-40.94]) and 60-fold more likely to receive SGLT-2 inhibitors (relative risk, 60.41 [95% CI, 15.99-228.22]) compared with beneficiaries in low-prescribing practices. Conclusions and Relevance: These findings suggest that there was substantial between-practice variation in the use of second-generation diabetes drugs between 2007 and 2015, with a concentration of use among a few prescribers and practices responsible for much of the early diffusion.

Expected vs Actual Outcomes of Elective Initiation of Inotropic Therapy During Heart Failure Hospitalization.

OBJECTIVE: To describe the intent and early outcomes of elective inotrope use during heart failure hospitalization. PATIENTS AND METHODS: A prospective multisite design was used to collect data for hemodynamically stable patients started electively on inotrope therapy between January 1 and August 31, 2018. We prospectively recorded data when intravenous inotropic therapy was initiated, including survey of the attending cardiologists regarding expectations for the clinical course. Patients were followed up for events through hospital discharge and an additional survey was administered at the end of hospitalization. RESULTS: For the 92 patients enrolled, average age was 60 years and ejection fraction was 24%±12%. At the time of inotrope initiation, attending heart failure cardiologists predicted that 50% (n=46) of the patients had a "high or very high" likelihood of becoming dependent on intravenous inotropic therapy and 58% (n=53) had a "high" likelihood of death, transplant, or durable ventricular assist device placement within the next 6 months. Provider predictions regarding death/hospice or need for continued home infusions were accurate only 51% (47 of 92) of the time. Only half the patients (n=47) had goals-of-care conversations before inotrope treatment initiation. CONCLUSION: More than half the patients (51 of 92) electively started on inotrope treatment without present or imminent cardiogenic shock ultimately required home inotrope therapy, died during admission, or were discharged with hospice. Heart failure clinicians could not reliably identify those patients at the time of inotrope therapy initiation and goals-of-care discussions were not frequently performed.

Social Risk Adjustment of Quality Measures for Diabetes and Cardiovascular Disease in a Commercially Insured US Population.

Importance: Patients' social risk factors may be associated with physician group performance on quality measures. Objective: To examine the association of social risk with change in physician group performance on diabetes and cardiovascular disease (CVD) quality measures in a commercially insured population. Design, Setting, and Participants: In this cross-sectional study using claims data from 2010 to 2014 from a US national health insurance plan, the performance of 1400 physician groups (physicians billing under the same tax identification number) was estimated. After base adjustments for age and sex, changes in variation across groups and reordering of rankings resulting from additional adjustments for clinical, social, or both clinical and social risk factors were analyzed. In all models, only within-group associations were adjusted to distinguish the association of patients' social risk factors with outcomes while excluding physician groups' distinct characteristics that could also change observed performance. Data analysis was conducted between April and July 2018. Main Outcomes and Measures: Process measures (hemoglobin A1c [HbA1c] testing, low-density lipoprotein cholesterol [LDL-C] testing, and statin use), disease control measures (HbA1c and LDL-C level control), and use-based outcome measures (hospitalizations for ambulatory-sensitive conditions) were calculated with base adjustment (age and sex), clinical adjustment, social risk factor adjustment, and both clinical and social adjustments. Quality variance in physician group performance and changes in rankings following these adjustments were measured. Results: This study identified 1 684 167 enrollees (859 618 [51%] men) aged 18 to 65 years (mean [SD] age, 50 [10.7] years) with diabetes or CVD. Performance rates were high for HbA1c and LDL-C level testing (mean ranged from 79.5% to 87.2%) but lower for statin use (54.7% for diabetes cohort and 44.2% for CVD cohort) and disease control measures (57.9% on LDL-C control for diabetes cohort and 40.0% for CVD cohort). On average, only 8.8% of enrollees with diabetes and 1.0% of enrollees with CVD in a group were hospitalized. The addition of clinical and social risk factors to base adjustment reduced variance across physician groups for most measures (percentage change in SD ranged from -13.9% to 1.6%). Although overall agreement between performance scores with base vs full adjustment was high, there was still substantial reordering for some measures. For example, social risk adjustment resulted in reordering for disease control in the diabetes cohort. Of the 1400 physician groups, 330 (23.6%) had performance rankings for HbA1c control that increased or decreased by at least 10 percentile points after adding social risk factors to age and sex. Both clinical and social risk adjustment affected rankings on hospital admissions. Conclusions and Relevance: Accounting for social risk may be important to mitigate adverse consequences of performance-based payments for physician groups serving socially vulnerable populations.

Epidemiology of Cardiac Amyloidosis-Associated Heart Failure Hospitalizations Among Fee-for-Service Medicare Beneficiaries in the United States.

Background Cardiac amyloidosis is a substantially underdiagnosed disease, and contemporary estimates of the epidemiology of amyloidosis are lacking. This study aims to determine the incidence and prevalence of cardiac amyloidosis among Medicare beneficiaries from 2000 to 2012. Methods and Results Medicare beneficiaries were counted in the prevalence cohort in each year they had (1) ≥1 principal or secondary International Classification of Diseases, Ninth Revision code for amyloidosis and (2) ≥1 principal or secondary International Classification of Diseases, Ninth Revision code for heart failure or cardiomyopathy within 2 years after the systemic amyloidosis code. A beneficiary was counted in the incidence cohort only during the first year in which they met criteria. Primary outcomes included the prevalence and incidence of hospitalizations for cardiac amyloidosis. There were 4746 incident cases of cardiac amyloidosis in 2012 and 15 737 prevalent cases in 2012. There was also a significant increase in the prevalence rate (8 to 17 per 100 000 person-years) and incidence rate (18 to 55 per 100 000 person-years) from 2000 to 2012, most notable after 2006. Incidence and prevalence increased substantially more among men, the elderly, and in blacks. Conclusions The incidence and prevalence rates of cardiac amyloidosis are higher than previously thought. The incidence and prevalence rates of cardiac amyloidosis among hospitalized patients have increased since 2000, particularly among specific patient subgroups and after 2006, suggesting improved amyloidosis awareness and higher diagnostic rates with noninvasive imaging. In light of these trends, cardiac amyloidosis should be considered during the initial work up of patients ≥65 years old hospitalized with heart failure.

Association Between Clinical Practice Group Adherence to Quality Measures and Adverse Outcomes Among Adult Patients With Diabetes.

Importance: Clinical practice group performance on quality measures associated with chronic disease management has become central to reimbursement. Therefore, it is important to determine whether commonly used process and disease control measures for chronic conditions correlate with utilization-based outcomes, as they do in acute disease. Objective: To examine the associations among clinical practice group performance on diabetes quality measures, including process measures, disease control measures, and utilization-based outcomes. Design, Setting, and Participants: This retrospective, cross-sectional analysis examined commercial claims data from a national health insurance plan. A cohort of eligible beneficiaries with diabetes aged 18 to 65 years who were enrolled for at least 12 months from January 1, 2010, through December 31, 2014, was defined. Eligible beneficiaries were attributed to a clinical practice group based on the plurality of their primary care or endocrinology office visits. Data were analyzed from October 1, 2018, through April 30, 2019. Main Outcomes and Measures: For each clinical practice group, performance on current diabetes quality measures included 3 process measures (2 testing measures [hemoglobin A1c {HbA1c} and low-density lipoprotein {LDL} testing] and 1 drug use measure [statin use]) and 2 disease control measures (HbA1c <8% and LDL level <100 mg/dL). The rates of utilization-based outcomes, including hospitalization for diabetes and major adverse cardiovascular events (MACEs), were also measured. Results: In this cohort of 652 258 beneficiaries with diabetes from 886 clinical practice groups, 42.9% were aged 51 to 60 years, and 52.6% were men. Beneficiaries lived in areas that were predominantly white (68.1%). At the clinical practice group level, except for high correlation between the 2 testing measures, correlations among different quality measures were weak (r range, 0.010-0.244). Rate of HbA1c of less than 8% had the strongest correlation with hospitalization for MACE (r = -0.046; P = .03) and diabetes (r = -0.109; P < .001). Rates of HbA1c control at the clinical practice group level were not significantly associated with likelihood of hospitalization at the individual level. Performance on the process and disease control measures together explained 3.9% of the variation in the likelihood of hospitalization for a MACE or diabetes at the individual level. Conclusions and Relevance: In this study, performance on utilization-based measures-intended to reflect the quality of chronic disease management-was only weakly associated with direct measures of chronic disease management, namely, disease control measures. This correlation should be considered when determining the degree of financial emphasis to place on hospitalization rates as a measure of quality in treatment of chronic diseases.

National Rates of Initiation and Intensification of Antidiabetic Therapy Among Patients With Commercial Insurance.

OBJECTIVE: Prompt initiation and intensification of antidiabetic therapy can delay or prevent complications from diabetes. We sought to understand the rates of and factors associated with the initiation and intensification of antidiabetic therapy among commercially insured patients in the U.S. RESEARCH DESIGN AND METHODS: Using 2008-2015 commercial claims linked with laboratory and pharmacy data, we created an initiation cohort with no prior antidiabetic drug use and an HbA1c ≥8% (64 mmol/mol) and an intensification cohort of patients with an HbA1c ≥8% (64 mmol/mol) who were on a stable dose of one noninsulin diabetes drug. Using multivariable logistic regression, we determined the rates of and factors associated with initiation and intensification. In addition, we determined the percent of variation in treatment patterns explained by measurable patient factors. RESULTS: In the initiation cohort (n = 9,799), 63% of patients received an antidiabetic drug within 6 months of the elevated HbA1c test. In the intensification cohort (n = 10,941), 82% had their existing antidiabetic therapy intensified within 6 months of the elevated HbA1c test. Higher HbA1c levels, lower generic drug copayments, and more frequent office visits were associated with higher rates of both initiation and intensification. Better patient adherence prior to the elevated HbA1c level, existing therapy with a second-generation antidiabetic drug, and lower doses of existing therapy were also associated with intensification. Patient factors explained 7.96% of the variation in initiation and 7.35% of the variation in intensification. CONCLUSIONS: Approximately two-thirds of patients were newly initiated on antidiabetic therapy, and four-fifths of those already receiving antidiabetic therapy had it intensified within 6 months of an elevated HbA1c in a commercially insured population. Patient factors explain 7-8% of the variation in diabetes treatment patterns.

Changes in Health Care Use Associated With the Introduction of Hospital Global Budgets in Maryland.

Importance: In 2014, the State of Maryland placed the majority of its hospitals under all-payer global budgets for inpatient, hospital outpatient, and emergency department care. Goals of the program included reducing unnecessary hospital utilization and encouraging greater use of primary care. Objective: To compare changes in hospital and primary care use through the first 2 years of Maryland's hospital global budget program among fee-for-service Medicare beneficiaries in Maryland vs matched control areas. Design, Setting, and Participants: We matched 8 Maryland counties (94 967 beneficiaries) with hospitals in the program to 27 non-Maryland control counties (206 389 beneficiaries). Using difference-in-differences analysis, we compared changes in hospital and primary care use in Maryland vs the control counties from before (2009-2013) to after (2014-2015) the payment change, using 2 different assumptions. First, we assumed that preintervention differences between Maryland and the control counties would have remained constant past 2014 had Maryland not implemented global budgets (parallel trend assumption). Second, we assumed that differences in preintervention trends would have continued without the payment change (differential trend assumption). Main Outcomes and Measures: Hospital stays (defined as admissions and observation stays); return hospital stays within 30 days of a prior hospital stay; emergency department visits that did not result in admission; price-standardized hospital outpatient department (HOPD) utilization; and visits with primary care physicians (overall and within 7 days of a hospital stay). Results: We matched 8 Maryland counties with hospitals in the program (94 967 beneficiaries; 41.8% male; mean [SD] age, 72.3 [12.2] years) to 27 non-Maryland control counties (206 389 beneficiaries; 42.8% male; mean [SD] age, 71.7 [12.5] years). Assuming parallel trends, we estimated a differential change in Maryland of -0.47 annual hospital stays per 100 beneficiaries (95% CI, -1.65 to 0.72; P = .43) from the preintervention period (2009-2013) to 2015, but assuming differential trends, we estimated a differential change in Maryland of -1.24 stays per 100 beneficiaries (95% CI, -2.46 to -0.02; P = .047). Assuming parallel trends, we found a significant increase in primary care visits (+10.6 annual visits/100 beneficiaries; 95% CI, 4.6 to 16.6 annual visits/100 beneficiaries; P = .001), but assuming differential trends, we found no change (-0.8 visits/100 beneficiaries; 95% CI, -10.6 to 9.0 visits/100 beneficiaries; P = .87). Comparing estimates with both trend assumptions, we found no consistent changes in emergency department visits, return hospital stays, HOPD use, or posthospitalization primary care visits associated with Maryland's program. Conclusions and Relevance: We did not find consistent evidence that Maryland's hospital global budget program was associated with reductions in hospital use or increases in primary care visits among fee-for-service Medicare beneficiaries after 2 years. Evaluations over longer periods should be pursued.