25 results on '"McClellan, Mark B"'
Search Results
2. Trends in inpatient treatment intensity among Medicare beneficiaries at the end of life
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Barnato, Amber E., McClellan, Mark B., Kagay, Christopher R., and Garber, Alan M.
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Hospitals -- Services ,Hospitals -- United States ,Terminal care -- Analysis ,Medicare -- Case studies ,Medical economics - Abstract
Objective. Although an increasing fraction of Medicare beneficiaries die outside the hospital, the proportion of total Medicare expenditures attributable to care in the last year of life has not dropped. We sought to determine whether disproportionate increases in hospital treatment intensity over time among decedents are responsible for the persistent growth in end-of-life expenditures. Data Source. The 1985-1999 Medicare Medical Provider Analysis and Review (MedPAR) and Denominator files. Study Design. We sampled inpatient claims for 20 percent of all elderly fee-for-service Medicare decedents and 5 percent of all survivors between 1985 and 1999 and calculated age-, race-, and gender-adjusted per-capita inpatient expenditures and rates of intensive care unit (ICU) and intensive procedure use. We used the decedent-to-survivor expenditure ratio to determine whether growth rates among decedents outpaced growth relative to survivors, using the growth rate among survivors to control for secular trends in treatment intensity. Data Collection. The data were collected by the Centers for Medicare and Medicaid Services. Principal Findings. Real inpatient expenditures for the Medicare fee-for-service population increased by 60 percent, from $58 billion in 1985 to $90 billion in 1999, one-quarter of which were accrued by decedents. Between 1983 and 1999 the proportion of beneficiaries with one or more intensive care unit (ICU) admission increased from 30.5 percent to 35.0 percent among decedents and from 5.0 percent to 7.1 percent among survivors; those undergoing one or more intensive procedure increased from 20.9 percent to 31.0 percent among decedents and from 5.8 percent to 8.5 percent among survivors. The majority of intensive procedures in the United States were performed in the more numerous survivors, although in 1999 50 percent of feeding tube placements, 60 percent of intubations/tracheostomies, and 75 percent of cardiopulmonary resuscitations were in decedents. The proportion of beneficiaries dying in a hospital decreased from 44.4 percent to 39.3 percent, but the likelihood of being admitted to an ICU or undergoing an intensive procedure during the terminal hospitalization increased from 38.0 percent to 39.8 percent and from 17.8 percent to 30.3 percent, respectively. One in five Medicare beneficiaries who died in the hospital in 1999 received mechanical ventilation during their terminal admission. Conclusions. Inpatient treatment intensity for all fee-for-service beneficiaries increased between 1985 and 1999 regardless of survivorship status. Absolute changes in per-capita hospital expenditures, ICU admissions, and intensive inpatient procedure use were much higher among decedents. Relative changes were similar except for ICU admissions, which grew faster among survivors. The secular decline in in-hospital deaths has not resulted in decreased per capita utilization of expensive inpatient services in the last year of life. This could imply that net hospital expenditures for the dying might have been even higher over this time period if the shift toward hospice had not occurred. Key Words. Medicare, end of life, elderly, health care expenditures, intensive care, Thirty percent of Medicare expenditures are attributable to the 5 percent of beneficiaries who die each year, resulting in per-capita spending on decedents that is six times as great as [...]
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- 2004
3. Cost-effectiveness of alternative management strategies for patients with solitary pulmonary nodules
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Gould, Michael K., Sanders, Gillian D., Barnett, Paul G., Rydzak, Chara E., Maclean, Courtney C., McClellan, Mark B., and Owens, Douglas K.
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Lung diseases -- Diagnosis ,PET imaging -- Economic aspects ,Cost benefit analysis ,Medical care, Cost of ,Cost benefit analysis ,Health - Published
- 2003
4. Remarks of the Commissioner of Food and Drugs.
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McClellan, Mark B.
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Drug approval -- Management ,Medical policy -- Management ,United States. Food and Drug Administration -- Management ,Company business management - Published
- 2003
5. Association of renal insufficiency with treatment and outcomes after myocardial infarction in elderly patients
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Shlipak, Michael G., Heidenreich, Paul A., Noguchi, Haruko, Chertow, Glenn M., Browner, Warren S., and McClellan, Mark B.
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Heart attack -- Prognosis ,Cardiac patients ,Kidney diseases -- Health aspects ,Health - Abstract
Background: patients with end-stage renal disease are known to have decreased survival after myocardial infarction, but the association of less severe renal dysfunction with survival after myocardial infarction is unknown. Objectives: To determine how patients with renal insufficiency are treated during hospitalization for myocardial infarction and to determine the association of renal insufficiency with survival after myocardial infarction. Design: Cohort study. Setting: All nongovernment hospitals, in the United States. Patients: 130 099 elderly patients with myocardial infarction hospitalized between April 1994 and July 1995. Measurements: Patients were categorized according to initial serum creatinine level: no renal insufficiency (creatinine level < 1.5 mg/dL [< 132 micromol/L]; n=82 455), mild renal insufficiency (creatinine levels, 1.5 to 2.4 mg/dL [132 to 212 micromol/L]; n=36 765), or moderate renal insufficiency (creatinine level, 2.5 to 3.9 mg/dL [221 to 345 micromol/L]; n=10 888). Vital status up to 1 year after discharge was obtained from Social Security records. Results: Compared with patients with no renal insufficiency, patients with moderate renal insufficiency were less likely to receive aspirin, beta-blockers, thrombolytic therapy, angiography, and angioplasty during hospitalization. One-year mortality was 24% in patients with no renal insufficiency, 46% in patients with mild renal insufficiency, and 66% in patients with moderate renal insufficiency (P Conclusions: Renal insufficiency was an independent risk factor for death in elderly patients after myocardial infarction. Targeted interventions may be needed to improve treatment for this high-risk population.
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- 2002
6. Effectiveness and cost-effectiveness of implantable cardioverter defibrillators in the treatment of ventricular arrhythmias among Medicare beneficiaries
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Weiss, J. Peter, Saynina, Olga, McDonald, Kathryn M., McClellan, Mark B., and Hlatky, Mark A.
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Arrhythmia -- Care and treatment ,Cost benefit analysis -- Reports ,Implantable cardioverter-defibrillators -- Economic aspects ,Health ,Health care industry - Published
- 2002
7. Managed care, health care quality, and regulation.
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Baker, Laurence C. and McClellan, Mark B.
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Managed care plans (Medical care) -- Laws, regulations and rules ,Quality control -- Laws, regulations and rules - Published
- 2001
8. The Past Decade of Paying for Value : From the Affordable Care Act to COVID-19
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Crook, Hannah, Whitaker, Rebecca, Bleser, William, Saunders, Robert, and McClellan, Mark B.
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The Affordable Care Act played a major role in transitioning American health care away from fee-for-service payment. We explore the spread of payment reforms since the implementation of the ACA, both nationally and in North Carolina; the corresponding effects on health care costs and quality; and further steps needed to achieve greater transformation.
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- 2020
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9. Medicare part D prescription coverage: what it means for primary care physicians
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McClellan, Mark B.
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Medicare -- Research ,Geriatrics -- Research ,Health ,Seniors - Abstract
For 40 years, Medicare has dependably covered primary care visits, hospital stays and life-saving surgeries for millions of Americans. That's a great record of supporting older Americans. But even successful [...]
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- 2005
10. Overview of the Special Supplement Issue
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McClellan, Mark B. and Newhouse, Joseph P.
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Instrumental variables (IV) analysis is a technique that virtually every econometrics textbook describes and that econometricians have employed for over half a century. It is used to contrast two or [...]
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- 2000
11. Payment Reform to Enhance Collaboration of Primary Care and Cardiology: A Review
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Farmer, Steven A., Casale, Paul N., Gillam, Linda D., Rumsfeld, John S., Erickson, Shari, Kirschner, Neil M., de Regnier, Kevin, Williams, Bruce R., Martin, R. Shawn, and McClellan, Mark B.
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IMPORTANCE: The US health care system faces an unsustainable trajectory of high costs and inconsistent outcomes. The fee-for-service payment model has contributed to inefficiency, and new payment methods are a promising approach to improving value. Health reforms are needed to increase patient access, reduce costs, and improve health care quality, and the landmark Medicare Access and CHIP Reauthorization Act presents a roadmap for reform. The product of a collaboration between primary care and cardiology clinicians, this review describes a conceptual approach to delivery and payment reforms that aim to better support primary care–cardiology comanagement of chronic cardiovascular disease (CVD). OBSERVATIONS: Few existing alternative payment models specifically address long-term management of CVD. Primary care medical homes and accountable care organizations come closest, but both emphasize primary care, and cardiologists have often not been well engaged. A collaborative care framework should articulate distinct roles and responsibilities for primary care and cardiology in CVD comanagement. Finally, a series of payment models aim to better support clinicians in providing accountable, seamless, and patient-centered cardiac care. CONCLUSIONS & RELEVANCE: Clinical leadership is essential during this time of change in the health care system. Patients often struggle to navigate a fragmented and expensive system, whereas clinicians often practice with incomplete information about tests, treatments, and recommendations by their colleagues. The payment models described in this review offer an opportunity to create more satisfying approaches to patient care while improving value. These models have potential to support more effective coordination and to facilitate broader health care system transformation.
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- 2018
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12. Moving Beyond the Walls of the Clinic
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Fraiche, Ariane M., Eapen, Zubin J., and McClellan, Mark B.
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Telehealth offers an innovative approach to improve heart failure care that expands beyond traditional management strategies. Yet the use of telehealth in heart failure is infrequent because of several obstacles. Fundamentally, the evidence is inconsistent across studies of telehealth interventions in heart failure, which limits the ability of cardiologists to make general conclusions. Where encouraging evidence exists, there are logistical challenges to broad-scale implementation as a result of insufficient understanding of how to transform telemedicine strategies into clinical practice effectively. Ultimately, when implementation is reasonable, the application of these efforts remains hampered by regulatory, reimbursement, and other policy issues. The primary aim of this paper is to describe these challenges and to outline a path forward to apply telehealth approaches to heart failure in conjunction with payment reform and pragmatic research study design.
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- 2017
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13. Existing and Emerging Payment and Delivery Reforms in Cardiology
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Farmer, Steven A., Darling, Margaret L., George, Meaghan, Casale, Paul N., Hagan, Eileen, and McClellan, Mark B.
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IMPORTANCE: Recent health care reforms aim to increase patient access, reduce costs, and improve health care quality as payers turn to payment reform for greater value. Cardiologists need to understand emerging payment models to succeed in the evolving payment landscape. We review existing payment and delivery reforms that affect cardiologists, present 4 emerging examples, and consider their implications for clinical practice. OBSERVATIONS: Public and commercial payers have recently implemented payment reforms and new models are evolving. Most cardiology models are modified fee-for-service or address procedural or episodic care, but population models are also emerging. Although there is widespread agreement that payment reform is needed, existing programs have significant limitations and the adoption of new programs has been slow. New payment reforms address some of these problems, but many details remain undefined. CONCLUSIONS AND RELEVANCE: Early payment reforms were voluntary and cardiologists’ participation is variable. However, conventional fee-for-service will become less viable, and enrollment in new payment models will be unavoidable. Early participation in new payment models will allow clinicians to develop expertise in new care pathways during a period of relatively lower risk.
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- 2017
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14. Why a Proactive Perioperative Medicine Policy Is Crucial for a Sustainable Population Health Strategy
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Aronson, Solomon, Sangvai, Dev, and McClellan, Mark B.
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- 2018
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15. Medicare Part D: Opportunities and Challenges for Pharmacy
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McClellan, Mark B.
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- 2005
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16. Utilization and outcomes of the implantable cardioverter defibrillator, 1987 to 1995
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Hlatky, Mark A., Saynina, Olga, McDonald, Kathryn M., Garber, Alan M., and McClellan, Mark B.
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BackgroundThe patterns of adoption of the implantable cardioverter defibrillator (ICD) and the outcomes of its use have not been well documented in general, unselected populations. The purpose of this study was to document the impact of the ICD in widespread clinical practice. MethodsWe identified ICD recipients by use of the hospital discharge databases of Medicare beneficiaries for 1987 through 1995 and of California residents for 1991 through 1995. The index admission for each patient was linked to previous and subsequent admissions and to mortality files to create a longitudinal patient profile. ResultsThe rate of ICD implantations increased >10-fold between 1987 and 1995, as both the number of hospitals performing the procedure and the volume of ICD implantations per hospital rose. Mortality rates within 30 days of ICD implantation decreased from 6.0% to 1.9%, and mortality rates within 1 year fell from 19.3% to 11.4%. Surgical interventions to revise or replace the ICD within the first year remained about 5%, however, and cumulative expenditures at 1 year ($46,000-$51,000) changed very little. ICD implantation rates varied >3-fold among different regions of the United States. ConclusionsICD use has expanded markedly during the study period, with improved mortality rates, but medical expenditures and rates of surgical revision remain high for ICD recipients. (Am Heart J 2002;144:397-403.)
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- 2002
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17. Trends in hospital treatment of ventricular arrhythmias among Medicare beneficiaries, 1985 to 1995
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McDonald, Kathryn M., Hlatky, Mark A., Saynina, Olga, Geppert, Jeffrey, Garber, Alan M., and McClellan, Mark B.
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BackgroundTreatment options for patients with ventricular arrhythmias have undergone major changes in the last 2 decades. Trends in use of invasive procedures, clinical outcomes, and expenditures have not been well documented. MethodsWe used administrative databases of Medicare beneficiaries from 1985 to 1995 to identify patients hospitalized with ventricular arrhythmias. We created a longitudinal patient profile by linking the index admission with all earlier and subsequent admissions and with death records. ResultsApproximately 85,000 patients aged ≥65 years went to hospitals in the United States with ventricular arrhythmias each year, and about 20,000 lived to admission. From 1987 to 1995, the use of electrophysiology studies and implantable cardioverter defibrillators in patients who were hospitalized grew substantially, from 3% to 22% and from 1% to 13%, respectively. Hospital expenditures rose 8% per year, primarily because of the increased use of invasive procedures. Survival improved, particularly in the medium term, with 1-year survival rates increasing between 1987 and 1994 from 52.9% to 58.3%, or half a percentage point each year. ConclusionSurvival of patients who sustain a ventricular arrhythmia is poor, but improving. For patients who are admitted, more intensive treatment has been accompanied by increased hospital expenditures. (Am Heart J 2002;144:413-21.)
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- 2002
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18. Inconsistent Reporting of Potential Conflicts of Interest in JAMA Pediatrics
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McClellan, Mark B.
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- 2019
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19. Improving Cardiovascular Drug and Device Development and Evidence Through Patient-Centered Research and Clinical Trials
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Warner, John J., Crook, Hannah L., Whelan, Karley M., Bleser, William K., Roiland, Rachel A., Hamilton Lopez, Marianne, Saunders, Robert S., Wang, Tracy Y., Hernandez, Adrian F., McClellan, Mark B., Califf, Robert M., and Brown, Nancy
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Supplemental Digital Content is available in the text.The pipeline of new cardiovascular drugs is relatively limited compared with many other clinical areas. Challenges causing lagging drug innovation include the duration and expense of cardiovascular clinical trials needed for regulatory evaluation and approvals, which generally must demonstrate noninferiority to existing standards of care and measure longer-term outcomes. By comparison, there has been substantial progress in cardiovascular device innovation. There has also been progress in cardiovascular trial participation equity in recent years, especially among women, due in part to important efforts by Food and Drug Administration, National Institutes of Health, American Heart Association, and others. Yet women and especially racial and ethnic minority populations remain underrepresented in cardiovascular trials, indicating much work ahead to continue recent success. Given these challenges and opportunities, the multistakeholder Partnering with Regulators Learning Collaborative of the Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University, identified how to improve the evidence generation process for cardiovascular drugs and devices. Drawing on a series of meetings, literature reviews, and analyses of regulatory options, the Collaborative makes recommendations across four identified areas for improvement. First, we offer strategies to enhance patient engagement in trial design, convenient participation, and meaningful end points and outcomes to improve patient recruitment and retention (major expenses in clinical trials). Second, new digital technologies expand the potential for real-world evidence to streamline data collection and reduce cost and time of trials. However, technical challenges must be overcome to routinely leverage real-world data, including standardizing data, managing data quality, understanding data comparability, and ensuring real-world evidence does not worsen inequities. Third, as trials are driven by evidence needs of regulators and payers, we recommend ways to improve their collaboration in trial design to streamline and standardize efficient and innovative trials, reducing costs and delays. Finally, we discuss creative ways to expand the minuscule proportion of sites involved in cardiovascular evidence generation and medical product development. These actions, paired with continued policy research into better ways to pay for and equitably develop therapies, will help reduce the cost and complexity of drug and device research, development, and trials.
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- 2020
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20. Streamlining and Reimagining Prior Authorization Under Value-Based Contracts: A Call to Action From the Value in Healthcare Initiative’s Prior Authorization Learning Collaborative
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Psotka, Mitchell A., Singletary, Elizabeth A., Bleser, William K., Roiland, Rachel A., Hamilton Lopez, Marianne, Saunders, Robert S., Wang, Tracy Y., McClellan, Mark B., and Brown, Nancy
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Supplemental Digital Content is available in the text.Utilization management strategies, including prior authorization, are commonly used to facilitate safe and guideline-adherent provision of new, individualized, and potentially costly cardiovascular therapies. However, as currently deployed, these approaches encumber multiple stakeholders. Patients are discouraged by barriers to appropriate access; clinicians are frustrated by the time, money, and resources required for prior authorizations, the frequent rejections, and the perception of being excluded from the decision-making process; and payers are weary of the intensive effort to design and administer increasingly complex prior authorization systems to balance value and appropriate use of these treatments. These issues highlight an opportunity to collectively reimagine utilization management as a transparent and collaborative system. This would benefit the entire healthcare ecosystem, especially in light of the shift to value-based payment. This article describes the efforts and vision of the multistakeholder Prior Authorization Learning Collaborative of the Value in Healthcare Initiative, a partnership between the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University. We outline how healthcare organizations can take greater utilization management responsibility under value-based contracting, especially under different state policies and local contexts. Even with reduced payer-mandated prior authorization in these arrangements, payers and healthcare organizations will have a continued shared need for utilization management. We present options for streamlining these programs, such as gold carding and electronic and automated prior authorization processes. Throughout the article, we weave in examples from cardiovascular care when possible. Although reimagining prior authorization requires collective action by all stakeholders, it may significantly reduce administrative burden for clinicians and payers while improving outcomes for patients.
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- 2020
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21. Frontiers of Upstream Stroke Prevention and Reduced Stroke Inequity Through Predicting, Preventing, and Managing Hypertension and Atrial Fibrillation
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Bufalino, Vincent J., Bleser, William K., Singletary, Elizabeth A., Granger, Bradi B., O’Brien, Emily C., Elkind, Mitchell S. V., Hamilton Lopez, Marianne, Saunders, Robert S., McClellan, Mark B., and Brown, Nancy
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Supplemental Digital Content is available in the text.Stroke is one of the leading causes of morbidity and mortality in the United States. While age-adjusted stroke mortality was falling, it has leveled off in recent years due in part to advances in medical technology, health care options, and population health interventions. In addition to adverse trends in stroke-related morbidity and mortality across the broader population, there are sociodemographic inequities in stroke risk. These challenges can be addressed by focusing on predicting and preventing modifiable upstream risk factors associated with stroke, but there is a need to develop a practical framework that health care organizations can use to accomplish this task across diverse settings. Accordingly, this article describes the efforts and vision of the multi-stakeholder Predict & Prevent Learning Collaborative of the Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University. This article presents a framework of a potential upstream stroke prevention program with evidence-based implementation strategies for predicting, preventing, and managing stroke risk factors. It is meant to complement existing primary stroke prevention guidelines by identifying frontier strategies that can address gaps in knowledge or implementation. After considering a variety of upstream medical or behavioral risk factors, the group identified 2 risk factors with substantial direct links to stroke for focusing the framework: hypertension and atrial fibrillation. This article also highlights barriers to implementing program components into clinical practice and presents implementation strategies to overcome those barriers. A particular focus was identifying those strategies that could be implemented across many settings, especially lower-resource practices and community-based enterprises representing broad social, economic, and geographic diversity. The practical framework is designed to provide clinicians and health systems with effective upstream stroke prevention strategies that encourage scalability while allowing customization for their local context.
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- 2020
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22. Advancing Value-Based Models for Heart Failure
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Joynt Maddox, Karen, Bleser, William K., Crook, Hannah L., Nelson, Adam J., Hamilton Lopez, Marianne, Saunders, Robert S., McClellan, Mark B., and Brown, Nancy
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Supplemental Digital Content is available in the text.Heart failure (HF) is a leading cause of hospitalizations and readmissions in the United States. Particularly among the elderly, its prevalence and costs continue to rise, making it a significant population health issue. Despite tremendous progress in improving HF care and examples of innovation in care redesign, the quality of HF care varies greatly across the country. One major challenge underpinning these issues is the current payment system, which is largely based on fee-for-service reimbursement, leads to uncoordinated, fragmented, and low-quality HF care. While the payment landscape is changing, with an increasing proportion of all healthcare dollars flowing through value-based payment models, no longitudinal models currently focus on chronic HF care. Episode-based payment models for HF hospitalization have yielded limited success and have little ability to prevent early chronic disease from progressing to later stages. The available literature suggests that primary care-based longitudinal payment models have indirectly improved HF care quality and cardiovascular care costs, but these models are not focused on addressing patients’ longitudinal chronic disease needs. This article describes the efforts and vision of the multi-stakeholder Value-Based Models Learning Collaborative of The Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University. The Learning Collaborative developed a framework for a HF value-based payment model with a longitudinal focus on disease management (to reduce adverse clinical outcomes and disease progression among patients with stage C HF) and prevention (an optional track to prevent high-risk stage B pre-HF from progressing to stage C). The model is designed to be compatible with prevalent payment models and reforms being implemented today. Barriers to success and strategies for implementation to aid payers, regulators, clinicians, and others in developing a pilot are discussed.
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- 2020
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23. Advancing Value-Based Cardiovascular Care
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McClellan, Mark B., Bleser, William K., and Joynt Maddox, Karen E.
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- 2020
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24. Inconsistent Reporting of Potential Conflicts of Interest in JAMA Cardiology
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McClellan, Mark B.
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- 2019
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25. A Call to Action: Important information to providers on the Medicare Part D benefit.
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McClellan, Mark B. and Jessee, William F.
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The article presents information on the Medicare Part D program which offers broad coverage of prescription drugs. Patients who participate in the Medicare inpatient and/or outpatient programs may voluntarily enroll in the Medicare Part D program. In addition to an annual deductible and copayment with each purchase, patients must pay a monthly premium to participate. There is also a financial assistance for those Medicare beneficiaries who require extra help. It is informed that the Social Security Administration already sent out applications to qualified patients.
- Published
- 2005
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