Association of the US Department of Justice Investigation of Implantable Cardioverter-Defibrillators and Devices Not Meeting the Medicare National Coverage Determination, 2007-2015.

Importance: The US Department of Justice (DOJ) conducted an investigation into implantable cardioverter-defibrillators (ICDs) not meeting the Centers for Medicare & Medicaid Services National Coverage Determination (NCD) criteria. Objective: To examine changes in the proportion of initial primary prevention ICDs that did not meet NCD criteria following the announcement of the DOJ investigation at hospitals that reached settlements (settlement hospitals) and those that did not (nonsettlement hospitals). Design, Setting, and Participants: Multicenter, longitudinal, serial cross-sectional analysis of 300 151 initial primary prevention ICDs among Medicare beneficiaries from January 1, 2007, through December 31, 2015, at 1809 US hospitals in the National Cardiovascular Data Registry (NCDR) ICD Registry, of which 452 hospitals (with 99 591 primary prevention ICDs) reached settlements with the DOJ. Exposures: The DOJ investigation announcement in 2010. Main Outcomes and Measures: Proportion of initial primary prevention ICDs not meeting NCD criteria. Results: In January 2007, the proportion of initial ICDs not meeting NCD criteria was 25.8% (95% CI, 24.7% to 26.8%) at settlement hospitals and 22.8% (95% CI, 22.1% to 23.5%) at nonsettlement hospitals (P < .001). Over the study period, there was a 62.7% (95% CI, 59.2% to 66.1%) relative decrease and 16.1% (95% CI, 14.8% to 17.5%) absolute decrease in the proportion of ICDs not meeting NCD criteria at settlement hospitals compared with a 53.2% (95% CI, 50.4% to 56.0%) relative decrease and 12.1% (95% CI, 11.2% to 13.0%) absolute decrease in proportion at nonsettlement hospitals (P < .001 for both; P for interaction < .001). Trends significantly differed between hospital groups only in the period following the announcement of the DOJ investigation (January 2010-June 2011) [corrected], with larger and more rapid decreases at settlement hospitals (P for interaction = .01). Over the study period, there was a 32.8% (95% CI, 29.9% to 35.7%) relative decrease and a 1703 ICDs (95% CI, 1520 to 1886) absolute decrease in the volume of primary prevention ICDs implanted at settlement hospitals compared with a 17.4% (95% CI, 14.8% to 20.0%) relative decrease and a 1495 ICDs (95% CI, 1249 to 1741) absolute decrease in volume at nonsettlement hospitals (P < .001 for both; P for interaction < .001), with more modest decreases or slight increases in secondary prevention ICD volume. These patterns were similar when examining ICD utilization among non-Medicare beneficiaries. Conclusions and Relevance: From 2007 through 2015, the volume of primary prevention implantable cardioverter-defibrillators and the proportion of devices not meeting the Centers for Medicare & Medicaid Services National Coverage Determination criteria decreased at all hospitals with substantially larger decreases at hospitals that reached settlements in the US Department of Justice investigation. These patterns extended to implantable cardioverter-defibrillators placed in non-Medicare beneficiaries, which were not the focus of the US Department of Justice investigation.

Comparison of performance on Hospital Compare process measures and patient outcomes between hospitals that do and do not participate in Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines.

BACKGROUND: Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines (ACTION Registry-GWTG) was designed to measure and improve the treatment and outcomes of patients with acute myocardial infarction (AMI), yet it is unknown whether performance of Medicare Hospital Compare metrics and outcomes differ between hospitals participating versus those not participating in the registry. METHODS: Using 2007 to 2010 Hospital Compare data, we matched participating to nonparticipating hospitals based on teaching status, size, percutaneous coronary intervention capability, and baseline (2007) Hospital Compare AMI process measure performance. We used linear mixed modeling to compare 2010 Hospital Compare process measure adherence, 30-day risk-adjusted mortality, and readmission rates. We repeated these analyses after stratification according to baseline performance level. RESULTS: Compared with nonparticipating hospitals, those participating were larger (median 288 vs 139 beds, P < .0001), more often teaching hospitals (18.8% vs 6.3%, P < .0001), and more likely had interventional catheterization lab capabilities (85.7% vs 34.0%, P < .0001). Among 502 matched pairs of participating and nonparticipating hospitals, we found high levels of process measure adherence in both 2007 and 2010, with minimal differences between them. Rates of 30-day mortality and readmission in 2010 were also similar between both groups. Results were consistent across strata of baseline performance level. CONCLUSIONS: In this observational analysis, there were no significant differences in the performance of Hospital Compare process measures or outcomes between hospitals in Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines and other hospitals not in the registry. However, baseline performance on the Hospital Compare process measures was very high in both groups, suggesting the need for new quality improvement foci to further improve patient outcomes.

Variation in performance measure criteria significantly affects cardiology practice rankings: Insights from the National Cardiovascular Data Registry's Practice Innovation and Clinical Excellence Registry.

BACKGROUND: Million Hearts is a national initiative to prevent 1 million heart attacks and strokes over 5 years by improving cardiovascular prevention. An important tool in the success of programs like Million Hearts is public ranking on the quality of practices, yet different measures may provide different rankings, so the true quality of practices is difficult to discern. We evaluated the quality of ambulatory cardiology care using performance measure metrics. METHODS: We compared rankings of practices participating in the National Cardiovascular Data Registry's Practice Innovation and Clinical Excellence Registry using measures from (1) the physician quality reporting system and (2) the American College of Cardiology/American Heart Association/Physician Consortium for Performance Improvement. We compared achievement rates for measures between the 2 frameworks and determined correlations in rankings using Spearman correlation coefficients. RESULTS: From January 1, 2008 to December 31, 2012, there were 1,711,326 patients enrolled from 111 US practices. Among eligible patients, the physician quality reporting system and American College of Cardiology/American Heart Association/Physician Consortium for Performance Improvement measures were achieved in 76.1% versus 77.4% for antiplatelet prescription (P < .001), 68.3% versus 90.8% for blood pressure control (P < .001), 26.9% versus 43.4% for cholesterol control (P < .001), and 37.4% versus 40.6% for smoking cessation (P = .383). Practice rankings were strongly correlated for antiplatelet prescription (correlation coefficient 0.98) and cholesterol control (0.92) but poorly correlated for blood pressure control (0.39) and smoking cessation (0.22). CONCLUSIONS: Evaluation of preventive care and individual practice rankings vary significantly depending on how measures are defined. Publicly reported measures need to be validly associated with outcomes to avoid incorrectly evaluating practice performance and failing to achieve public health goals.

Medical professional liability risk among US cardiologists.

BACKGROUND: Medical professional liability (MPL) remains a significant burden for physicians, in general, and cardiologists, in particular, as recent research has shown that average MPL defense costs are higher in cardiology than other specialties. Knowledge of the clinical characteristics and outcomes of lawsuits against cardiologists may improve quality of care and risk management. METHODS: We analyzed closed MPL claims of 40,916 physicians and 781 cardiologists insured by a large nationwide insurer for ≥1 policy year between 1991 and 2005. RESULTS: The annual percentage of cardiologists facing an MPL claim was 8.6%, compared with 7.4% among physicians overall (P < .01). Among 530 claims, 72 (13.6%) resulted in an indemnity payment, with a median size of $164,988. Mean defense costs for claims resulting in payment were $83,593 (standard deviation (s.d.) $72,901). The time required to close MPL claims was longer for claims with indemnity payment than claims without (29.6 versus 18.9 months; P < .001). More than half of all claims involved a patient's death (304; 57.4%), were based on inpatient care (379; 71.5%), or involved a primary cardiovascular condition (416; 78.4%). Acute coronary syndrome was the most frequent condition (234; 44.2%). Medical professional liability claims involving noncardiovascular conditions were common (66; 12.5%) and included falls or mechanical injuries had while under a cardiologist's care and a failure to diagnose cancer. CONCLUSIONS: Rates of malpractice lawsuits are higher among cardiologists than physicians overall. A substantial portion of claims are noncardiovascular in nature.

Influenza and coronary artery disease: exploring a clinical association with myocardial infarction and analyzing the utility of vaccination in prevention of myocardial infarction.

Both coronary artery disease and influenza outbreaks contribute significantly to worldwide morbidity and mortality. An increasing number of epidemiologic studies have concluded that a temporal association exists between acute viral illnesses and myocardial infarction. Viral illnesses such as influenza can cause or exacerbate coronary atherosclerosis by activating inflammatory pathways. Data from a large case-controlled trial and two randomized controlled trials suggest that influenza vaccination in patients with coronary artery disease may lead to a decrease in incidence, morbidity, and mortality from acute myocardial infarction. A meta-analysis of the two randomized controlled trials for cardiovascular death demonstrated a pooled relative risk of 0.39 (95% confidence interval, 0.20-0.77) for patients who received the influenza vaccine compared with placebo.

Reducing risk; click by click.

A heart health initiative is a perfect fit for a system's EHR.

Characteristics of medical professional liability claims against dermatologists: data from 2704 closed claims in a voluntary registry.

BACKGROUND: The Physician Insurers Association of America established a voluntary registry in 1985 that contains 239,756 closed claims. The registry is maintained for educational programs to reduce patient injury and medical professional liability (MPL) claims. OBJECTIVE: This report provides a description of MPL claims against dermatologists. METHODS: Descriptive techniques are used to present summary information for the dermatologic claims in the registry. RESULTS: Of 239,756 closed claims, 2704 (1.1%) involve dermatologists. Of the 2704 closed claims, 775 (28.7%) resulted in an average indemnity payment of $137,538. The most common allegation was improper procedure performance. The most prevalent procedure was operative procedures on the skin. Error in diagnosis was the next most common allegation. The most common diagnosis was malignant melanoma. Malignant melanoma claims were paid in 42.2% of cases with an average indemnity payment of $436,843. LIMITATIONS: The data are subject to selection and reporting biases. In addition, the registry does not contain exposure data, so incidences and prevalences are not calculable. CONCLUSIONS: MPL issues are important to all practicing dermatologists. The most common allegation against dermatologists in this study was improper performance of operative procedures on the skin, excluding skin grafts. Error in diagnosis of malignant melanoma was the next most common allegation. Malignant melanoma claims were paid in 42.2% of cases with an average indemnity payment of $436,843. By focusing on the risk management of these procedures and this diagnosis, dermatologists can have the largest impact on reducing patient injuries and consequent MPL claims.

First, do no harm. Mandatory influenza vaccination for health care workers is a matter of patient safety.

A commitment to patient safety drove a system's decision to require influenza vaccination of employees.

Maintenance of Competence in Cardiovascular Training and Practices: Worth the Effort?

Americans expect their doctors to have the competence to deliver high-quality care and expect safeguards to be in place that assure their doctors are competent. However, competence requires knowledge, and people have trouble assessing their own knowledge and level of competence. Because external assessment is required, several organizations have taken on the roles of defining and assuring medical competence. For example, professional organizations such as the American College of Cardiology (ACC) have developed consensus documents that define core competencies for cardiologists. External organizations such as the Accreditation Council for Graduate Medical Education and the American Board of Internal Medicine (ABIM) have defined training requirements for cardiologists, and the ABIM has developed a process to certify that physicians maintain their competence, although the process has generated considerable criticism from the profession. Recently, the ACC and ABIM have worked together to make the certification process less onerous and more meaningful. This paper provides a brief summary of the history and ongoing efforts to assure the competence of cardiologists.

Trends in U.S. Ambulatory Cardiovascular Care 2013 to 2017: JACC Review Topic of the Week.

The National Cardiovascular Data Registry PINNACLE (Practice Innovation and Clinical Excellence) Registry is the largest outpatient cardiovascular practice registry in the world. It tracks real-world management and quality of 4 common cardiovascular conditions: heart failure, coronary artery disease, atrial fibrillation, and hypertension. In 2013, the PINNACLE Registry contained information on 2,898,505 patients, cared for by 4,859 providers in 431 practices. By 2017, the registry contained information on 6,040,996 patients, cared for by 8,853 providers in 724 practices. During this time period, care processes for PINNACLE patients generally improved. Among patients with heart failure, combined beta-blocker and renin-angiotensin antagonist medication rates increased from 60.7% to 72.8%. Among patients with coronary artery disease, statin medication rates increased from 66% to 80.1%. Among patients with atrial fibrillation, oral anticoagulation rates increased from 52.7% to 65.2%. In contrast, blood pressure control rates among patients with hypertension were largely stable. PINNACLE data also fueled a variety of quality measurement programs and 51 peer-reviewed publications.

Characterization of Medical Professional Liability Risks Associated With Transesophageal Echocardiography.

BACKGROUND: Medical claim data offer the possibility to improve patient care and mitigate liability. Although published analyses exist in cardiology, no information is available for transesophageal echocardiography (TEE). In this study, the authors reviewed medical claims involving TEE to identify potential risk management concerns so that these lessons could be used to improve the safety and quality of transesophageal echocardiographic practice. METHODS: The authors reviewed anonymized clinical and claims data from all closed claims from 2008 to 2013 for a single national physician liability insurer. RESULTS: There were no claims involving transthoracic echocardiography and eight involving TEE. Three claims involved esophageal perforation, a known risk of TEE. Two claims involved quadriplegia allegedly due to neck manipulation in the setting of a cervical spinal abscess that should have been suspected. Three claims involved the cardiologist's failure to diagnose endocarditis, with allegations that the cardiologist did not perform TEE in an appropriate time frame to avoid major morbidity and mortality from endocarditis. CONCLUSIONS: Liability claims associated with TEE involve failure to order and perform TEE in an appropriate clinical scenario and in a timely manner; failure to properly document medical decision making; failure to inform patients regarding risks of TEE; failure to properly monitor the patient before, during, and after TEE; and technical difficulties in performing the procedure. Cardiologists should recognize guideline-based indications when TEE is needed and be mindful of the complication rates of this procedure. When screening a patient for TEE, consider expert input that may reduce the risks of TEE (e.g., a spine specialist for a neck injury, a gastroenterologist for esophageal comorbidity). Informed consent and medical record documentation should be practiced as a vehicle to inform patients of these risks and chronicle decision-making processes.

Current Demographic Status of Cardiologists in the United States.

Importance: Increasing cardiology workforce diversity will expand the talent of the applicant pool and may reduce health care disparities. Objective: To assess US cardiology physician workforce demographics by sex and race/ethnicity in the context of the US population and the available pipelines of trainees. Design, Setting, and Participants: This cross-sectional study used data from the Association of American Medical Colleges, the American Medical Association, and the American Board of Internal Medicine to stratify medical students, resident physicians, fellows, and cardiologists by sex and race/ethnicity. Additionally, proportional changes from 2006 through 2016 were assessed for adult and pediatric cardiology. Data analysis took place from August 2018 to January 2019. Main Outcomes and Measures: Percentage of cardiologists and trainees by sex and race/ethnicity in 2016, as well as changes in proportions between 2006 and 2016. Results: Despite a high percentage of female internal medicine resident physicians (10 765 of 25 252 [42.6%]), female physicians were underrepresented in adult general cardiology fellowships (584 of 2720 [21.5%]) and procedural subspecialty fellowships (interventional cardiology, 30 of 305 [9.8%]; electrophysiology, 24 of 175 [13.7%]). The percentage of female adult cardiologists slightly increased from 2006 through 2016 (from 8.9% to 12.6%; slope, 0.36; P < .001) but remained low. Female physicians made up a disproportionately higher number of pediatric residency positions (6439 of 8832 [72.9%]). Trends showed an increase in female pediatric cardiology fellows (from 40.4% to 50.5%; slope, 1.25; P < .001), which resulted in an increase in the percentage of female pediatric cardiologists (from 27.1% to 34.0%; slope, 0.64; P < .001). The percentages of members of underrepresented minority groups in adult and pediatric cardiology fellowships (from 11.1% to 12.4%; slope, 0.15; P = .01; and from 7.7% to 9.9%; slope, 0.29; P = .009; respectively) were low and increased only slightly over time. Additionally, members of underrepresented minorities made up less than 8% of practicing adult and pediatric cardiologists. Although Asian individuals are 5.2% of the US general population, they are not considered underrepresented because they are 22.1% of US medical school graduates (n = 4202 of 18 999), 38.1% of internal medicine resident physicians (n = 9618 of 25 252), 40.4% of adult cardiology fellows (n = 1098 of 2720), 19.9% of adult cardiologists (n = 5973 of 30 016), 22.6% of pediatric resident physicians (n = 1998 of 8832), 28.0% of pediatric cardiology fellows (n = 122 of 436), and 20.1% of pediatric cardiologists (n = 574 of 2860). Conclusions and Relevance: Female physicians remain underrepresented in adult cardiology, despite a robust pipeline of female medical students and internal medicine resident physicians. Women in pediatric cardiology are underrepresented but increasing in number. Members of several racial/ethnic minority groups remain underrepresented in adult and pediatric cardiology, and the percentages of trainees and medical students from these groups were also low. Different strategies are needed to address the continuing lack of diversity in cardiology for underrepresented minority individuals and women.

A Comparative Analysis of Current Lipid Treatment Guidelines: Nothing Stands Still.

Lipid treatment guidelines have continued to evolve as new evidence emerges. We sought to review similarities and differences of 5 lipid treatment guidelines from the American College of Cardiology/American Heart Association, Canadian Cardiovascular Society, European Society for Cardiology/European Atherosclerosis Society, U.S. Preventive Services Task Force, and U.S. Veterans Affairs/Department of Defense. All guidelines utilize rigorous evidentiary review, highlight statin therapy for primary and secondary prevention of atherosclerotic cardiovascular disease, and emphasize a clinician-patient risk discussion. However, there are differences in statin intensities, use of risk estimators, treatment of specific patient subgroups, and consideration of safety concerns. Clinicians should understand these similarities and differences in current and future guideline recommendations when considering if and how to treat their patients with statin therapy.

Electronic health records and outpatient cardiovascular disease care delivery: Insights from the American College of Cardiology's PINNACLE India Quality Improvement Program (PIQIP).

BACKGROUND: There has been a push toward implementation of electronic health records (EHRs) in federally-funded hospitals under the current policies initiated by the Indian government, with a lack of evidence supporting their adoption. We analyzed data from the American College of Cardiology's PINNACLE (Practice Innovation and Clinical Excellence) India Quality Improvement Program (PIQIP) to evaluate the association between EHR use and quality of cardiovascular disease care in India. METHODS AND RESULTS: Between 2011-2016, we collected data on performance measures for patients with coronary artery disease (CAD), heart failure (HF) and atrial fibrillation (AF) among 17 participating practices in PIQIP. There were 19,035 patients with CAD, 9,373 patients with HF, and 1,127 patients with AF. Documentation of co-morbidity burden in patients with CAD was lower among practices with EHR-hypertension (49.8% vs. 52.1%, p=0.003), diabetes (34.9% vs. 38.3%, p<0.001), and hyperlipidemia (0.2 vs. 3.9%, p<0.001). On the contrary, documentation of medication prescription was higher in CAD patients seen at practices with EHR-aspirin (63.2% vs. 17.8%, p<0.001), clopidogrel (41.7% vs. 27.4%, p<0.001), beta-blockers (61.4% vs. 9.8%, p<0.001), and ACE-i or ARBs (53.9% vs. 16.4%, p<0.001). Similarly, documentation of receipt of beta-blockers (43.8% vs. 10.7%, p<0.001), ACE-i or ARBs (40.8% vs. 16.1%, p<0.001), and beta-blockers+ACE-i or ARBs (36.4% vs. 3.6%, p<0.001) was also significantly higher in patients with HF seen at practices with EHR. Among patients with AF, documentation of oral anticoagulation use was significantly higher among EHR practices-warfarin (42.5% vs. 26.1%, p<0.001). CONCLUSIONS: Documentation of receipt of guideline-directed medical therapy in CAD, HF, and AF was significantly higher in practices with EHRs in India compared with sites without EHRs. Our findings shed a spotlight on the value of EHRs in future health care policy-making in India with regard to widespread adoption of EHRs in primary and advanced specialty care settings across public and private sectors.

Adoption of the 2013 American College of Cardiology/American Heart Association Cholesterol Management Guideline in Cardiology Practices Nationwide.

Importance: The 2013 American College of Cardiology/American Heart Association (ACC/AHA) Cholesterol Management Guideline recommends moderate-intensity to high-intensity statin therapy in eligible patients. Objective: To examine adoption of the 2013 ACC/AHA guideline in US cardiology practices. Design, Setting, and Participants: Among 161 cardiology practices, trends in the use of moderate-intensity to high-intensity statin and nonstatin lipid-lowering therapy (LLT) were analyzed before (September 1, 2012, to November 1, 2013) and after (February 1, 2014, to April 1, 2015) publication of the 2013 ACC/AHA guideline among 4 mutually exclusive risk groups within the ACC Practice Innovation and Clinical Excellence Registry. Interrupted time series analysis was used to evaluate for differences in trend in use of moderate-intensity to high-intensity statin and nonstatin LLT use in hierarchical logistic regression models. Participants were a population-based sample of 1 105 356 preguideline patients (2 431 192 patient encounters) and 1 116 472 postguideline patients (2 377 219 patient encounters). Approximately 97% of patients had atherosclerotic cardiovascular disease (ASCVD). Exposures: Moderate-intensity to high-intensity statin and nonstatin LLT use before and after publication of the 2013 ACC/AHA guideline. Main Outcomes and Measures: Time trend in the use of moderate-intensity to high-intensity statin and nonstatin LLT. Results: In the study cohort, the mean (SD) age was 69.6 (12.1) years among 1 105 356 patients (40.2% female) before publication of the guideline and 70.0 (11.9) years among 1 116 472 patients (39.8% female) after publication of the guideline. Although there was a trend toward increasing use of moderate-intensity to high-intensity statins overall and in the ASCVD cohort, such a trend was already present before publication of the guideline. No significant difference in trend in the use of moderate-intensity to high-intensity statins was observed in other groups. The use of moderate-intensity to high-intensity statin therapy was 62.1% (before publication of the guideline) and 66.6% (after publication of the guideline) in the overall cohort, 62.7% (before publication) and 67.0% (after publication) in the ASCVD cohort, 50.6% (before publication) and 52.3% (after publication) in the cohort with elevated low-density lipoprotein cholesterol levels (ie, ≥190 mg/dL), 52.4% (before publication) and 55.2% (after publication) in the diabetes cohort, and 41.9% (before publication) and 46.9% (after publication) in the remaining group with 10-year ASCVD risk of 7.5% or higher. In hierarchical logistic regression models, there was a significant increase in the use of moderate-intensity to high-intensity statins in the overall cohort (4.8%) and in the ASCVD cohort (4.3%) (P < .01 for slope for both). There was no significant change for other risk cohorts. Nonstatin LLT use remained unchanged in the preguideline and postguideline periods in the hierarchical logistic regression models for all of the risk groups. Conclusions and Relevance: Adoption of the 2013 ACC/AHA Cholesterol Management Guideline in cardiology practices was modest. Timely interventions are needed to improve guideline-concordant practice to reduce the burden of ASCVD.