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Patient access to a drug after US regulatory approval is controlled by complex interactions between governmental and third-party payers, pharmacy benefit managers, distributers, manufacturers, health systems, and pharmacies that together mediate the receipt of goods by patients after prescription by clinicians. Recent medication approvals highlight why and how the distribution of clinically beneficial novel therapies is controlled. Although imposed limitations on availability may be rational considering the fiduciary responsibilities of payers and escalating spending on health care and pharmaceuticals, transparency and communication are lacking, and some utilization management may disproportionately affect vulnerable populations. Analysis of the current health insurance landscape suggests mechanisms by which patient access to appropriate medications can be improved and patient and clinician frustration reduced while acknowledging the financial realities of the pharmaceutical marketplace. We propose creation of a shared, standardized, and transparent process for coverage decisions that minimizes administrative barriers and is defensible on the basis of clinical and cost-effectiveness evidence. These reforms would benefit patients and improve the efficiency of the pharmaceutical system.

In an effort to curb excessive health care spending and incentivize high-quality care, many payers have implemented value-based payment reforms designed to pay for the quality rather than the quantity of health care services. Medicare, the largest payer in the United States, has implemented numerous value-based payment policies over the past decade, many of which affect cardiovascular care. In this review, we discuss some of these major nationwide value-based payment reforms as they relate to cardiovascular care and what we may expect in the future from cardiovascular value-based policies., Competing Interests: Conflict of Interest Disclosure: The authors have completed and submitted the Methodist DeBakey Cardiovascular Journal Conflict of Interest Statement and none were reported., (© 2020 Houston Methodist Hospital Houston, Texas.)

Over the past two decades, Medicare and other payers have been looking at ways to base payment for cardiovascular care on the quality and outcomes of care delivered. Public reporting of hospital performance on a series of quality measures began in 2004 with basic processes of care such as aspirin use and influenza vaccination, and it expanded in later years to include outcomes such as mortality and readmission rates. Following the passage of the Affordable Care Act in March 2010, Medicare and other payers moved forward with pay-for-performance programs, more commonly referred to as value-based purchasing (VBP) programs. These programs are largely based on an underlying fee-for-service payment infrastructure and give hospitals and clinicians bonuses or penalties based on their performance. Another new payment mechanism, called alternative payment models (APMs), aims to move towards episode-based or global payments to improve quality and efficiency. The two most relevant APMs for cardiovascular care include Accountable Care Organizations and bundled payments. Both VBP programs and APMs have challenges related to program efficacy, accuracy, and equity. In fact, despite over a decade of progress in measuring and incentivizing high-quality care delivery within cardiology, major limitations remain. Many of the programs have had little benefit in terms of clinical outcomes yet have led to marked administrative burden for participants. However, there are several encouraging prospects to aid the successful implementation of value-based high-quality cardiovascular care, such as more sophisticated data science to improve risk adjustment and flexible electronic health records to decrease administrative burden. Furthermore, payment models designed specifically for cardiovascular care could incentivize innovative care delivery models that could improve quality and outcomes for patients. This review provides an overview of current efforts, largely at the federal level, to pay for high-quality cardiovascular care and discusses the challenges and prospects related to doing so., Competing Interests: Conflict of Interest Disclosure: Dr. Joynt Maddox does contract work for the United States Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation. There are no other financial conflicts of interest to report., (© 2020 Houston Methodist Hospital Houston, Texas.)

European guidelines on cardiovascular prevention in clinical practice were first published in 1994 and have been regularly updated, most recently in 2016, by the Sixth European Joint Task Force. Given the amount of new information that has become available since then, components from the task force and experts from the European Association of Preventive Cardiology of the European Society of Cardiology were invited to provide a summary and critical review of the most important new studies and evidence since the latest guidelines were published. The structure of the document follows that of the previous document and has six parts: Introduction (epidemiology and cost effectiveness); Cardiovascular risk; How to intervene at the population level; How to intervene at the individual level; Disease-specific interventions; and Settings: where to intervene? In fact, in keeping with the guidelines, greater emphasis has been put on a population-based approach and on disease-specific interventions, avoiding re-interpretation of information already and previously considered. Finally, the presence of several gaps in the knowledge is highlighted.

Background: Cardiovascular disease (CVD) remains the leading cause of morbidity and mortality worldwide. In response, a multidisciplinary team approach, which includes clinical pharmacists, is recommended to improve patient outcomes. The purpose of the study was to describe interventions associated with integration of a clinical pharmacist, with an emphasis on pharmacist-generated patient cost avoidance. Methods: This is a prospective observational study detailing pharmacist-initiated interventions within an academic preventive cardiology service. Interventions targeting pharmacotherapy optimization, side effect management, patient education, medication adherence, and cost avoidance were implemented during shared office visits with providers and/or on provider consultation for remote follow-up. Tabulation of cost avoidance was arranged into 2 formats: clinical interventions implemented by the pharmacist and direct patient out-of-pocket expense reduction. Money saved per clinical intervention was extrapolated from data previously published. Patient out-of-pocket expense prior to and after pharmacist involvement was calculated to assess aggregate yearly patient cost savings. Results: Over 12 months the pharmacist intervened on 974 patients, totaling 3725 interventions. Cost avoidance strategies resulted in yearly savings of $830 748 in aggregate-$149 566 from clinical interventions and $681 182 from patient out-of-pocket expense reduction. Monthly patient out-of-pocket expense was reduced from a median (interquartile range) of $217 ($83.5-$347) before to $5 ($0-$18) after pharmacist intervention. Conclusions : Addition of a clinical pharmacist within an academic preventive cardiology clinic generated substantial pharmacotherapy interventions, resulting in significant cost avoidance for patients. The resulting cost avoidance may result in improved medication adherence and clinical outcomes.

As we commemorate the 70 th Anniversary of the National Heart, Lung, and Blood Institute (NHLBI) and celebrate important milestones that have been achieved by the Division of Cardiovascular Sciences (DCVS), it is imperative that DCVS and the Extramural Research community at-large continue to address critical public health challenges that persist within the area of Cardiovascular Diseases (CVD). The NHLBI's Strategic Vision, developed with extensive input from the extramural research community and published in 2016, included overarching goals and strategic objectives that serve to provide a general blueprint for sustaining the legacy of the Institute by leveraging opportunities in emerging scientific areas (e.g., regenerative medicine, omics technology, data science, precision medicine, and mobile health), finding new ways to address enduring challenges (e.g., social determinants of health, health inequities, prevention, and health promotion), and training the next generation of heart, lung, blood, and sleep researchers. DCVS has developed a strategic vision implementation plan to provide a cardiovascular framing for the pursuit of the Institute's overarching goals and strategic objectives garnered from the input of the broader NHLBI community. This plan highlights six scientific focus areas that demonstrate a cross-cutting and multifaceted approach to addressing cardiovascular sciences, including 1) addressing social determinants of cardiovascular health (CVH) and health inequities, 2) enhancing resilience, 3) promoting CVH and preventing CVD Across the lifespan, 4) eliminating hypertension-related CVD, 5) reducing the burden of heart failure, and 6) preventing vascular dementia. These priorities will guide our efforts in Institute-driven activities in the coming years but will not exclude development of other novel ideas or the support of investigator-initiated grant awards. The DCVS Strategic Vision implementation plan is a living document that will evolve with iterative dialogue with the NHLBI community and adapt as the dynamic scientific landscape changes to seize emerging opportunities., Competing Interests: Disclosures: None of the authors have relationships with industry or conflicts of interest to disclose. The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; National Institutes of Health; or the United States Department of Health and Human Services.

We are presently seeing exponential advances in medical knowledge and development of therapeutic and diagnostic tools. We have also begun to experience an historic restructuring of our health care system. But health care costs continue to rise, disparities persist, and the chaotic, disjointed, and often thoughtless discourse in Washington threatens to roll back the prior advances. Improvement in patient care will be severely stymied if the threats to academic medical centers are not countered. This paper will explore our present state through the lens of cardiovascular care. It will 1) examine clinical trends; 2) dissect the value and challenges to the Patient Protection and Affordable Care Act; 3) highlight limitations and alternatives to relying on the federal government; and 4) present the Academic Medical System construct, as a structure designed to retain and advance the academic mission., Competing Interests: Potential Conflicts of Interest: None disclosed.

The quality-adjusted life year (QALY) and incremental cost-effectiveness ratio (ICER) are important concepts in cost-effectiveness analysis, which is becoming increasingly important in Japan. QALY is used to estimate quality of life (QOL) and life years, and can be used to compare the efficacies of cancer and cardiovascular treatments. ICER is defined as the difference in cost between treatments divided by the difference in their effects, with a smaller ICER indicating better cost-effectiveness. Here, we present a review of cost-effectiveness analyses in Japan as well other countries. A number of treatments were shown to be cost-effective, e.g., statin for secondary prevention of cardiovascular disease, aspirin for primary prevention of cardiovascular disease, DOAC for high-risk atrial fibrillation, beta blockers, ACE inhibitors, and ARB for heart failure, sildenafil and bosentan for pulmonary hypertension, CABG for multi-vessel coronary disease, ICD for ventricular tachycardia, and CRT for heart failure with low ejection fraction, while others were not cost-effective, e.g., epoprostenol for pulmonary hypertension and LVAD for end-stage heart failure. Further investigations are required regarding some treatments, e.g., PCSK-9 inhibitors for familial hypercholesterolemia, PCI for multi-vessel coronary disease, catheter ablation for atrial fibrillation, and TAVI for severe aortic stenosis. Ethical aspects should be taken into consideration when utilizing the results of cost-effectiveness analysis in medical policy.

We conducted a study to assess test characteristics of red-flag criteria for identifying cardiac disease causing chest pain and technical charges of low-probability referrals. Accuracy of red-flag criteria was ascertained through study of chest pain Standardized Clinical Assessment and Management Plans (SCAMPs®) data. Patients were divided into 2 groups: Group1 (concerning clinical elements) and Group2 (without). We compared incidence of cardiac disease causing chest pain between these 2 groups. Technical charges of Group 2 were analyzed using the Pediatric Health Information System database. Potential savings for the US population was estimated using National Ambulatory Medical Care Survey data. Fifty-two percent of subjects formed Group 1. Cardiac disease causing chest pain was identified in 8/1656 (0.48%). No heart disease was identified in patients in Group 2 ( P = .03). Applying red-flags in determining need for referral identified patients with cardiac disease causing chest pain with 100% sensitivity. Median technical charges for Group 2, over a 4-year period, were US2014$775 559. Eliminating cardiac testing of low-probability referrals would save US2014$3 775 182 in technical charges annually. Red-flag criteria were an effective screen for children with chest pain. Eliminating cardiac testing in children without red-flags for referral has significant technical charge savings.

Background: Appropriate dissemination of clinical data is crucial for minimising bias. Despite this, high rates of study discontinuation and non-publication have been reported among clinical trials. Cardiovascular medicine receives a substantial proportion of academic funding; however, predictors of non-publication among cardiovascular trials are not well-established., Methods: The National Clinical Trials database was searched for cardiovascular trials completed between January 2010 and January 2014. Associated publications were identified in Medline or Embase. Relevant variables were extracted and subject to chi-squared and logistic regression to identify predictors of discontinuation and non-publication., Results: After reviewing 2035 trials, 431 trials were included, of which 82.1% (n=354; 119,233 participants) were completed. Among completed trials, 70.3% (n=249; 99,095 participants) were published. Industry funding was associated with increased likelihood of non-publication (odds ratio [OR] 2.84; 95% confidence interval [CI] 1.47-5.51; P=0.002), while non-randomised studies were more likely to remain unpublished than randomised counterparts. Industry-funded studies were over three times more likely to be discontinued than those sponsored by academic institutions (OR 3.89; CI 1.54-9.83; P=0.004). Trials studying heart failure and atrial fibrillation were more likely to be discontinued compared to trials studying coronary artery disease (OR 2.83; CI 1.23-6.51; and OR 3.10; CI 1.21-7.96, respectively). Of the total 135,714 participants, 25,565 were recruited into unpublished studies., Conclusions: Discontinuation and non-publication of cardiovascular trials are common, resulting in data from thousands of participants remaining unpublished. Funding source and randomisation are strong predictors of non-publication, while sponsor type, phase and blinding status are key predictors of discontinuation., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Background: We previously demonstrated that cardiovascular (CV) trials funded by the National Heart, Lung, and Blood Institute (NHLBI) were more likely to be published in a timely manner and receive high raw citation counts if they focused on clinical endpoints. We did not examine the metrics of trial reports, and our citation measures were limited by failure to account for topic-related citation behaviors., Methods and Results: Of 244 CV trials completed between 2000 and 2011, we identified 184 whose main results were published by August 20, 2014. One investigator who was blinded to rapidity of publication and citation data read each publication and characterized it according to modified Delphi criteria. There were 46 trials (25%) that had Delphi scores of 8 or 9 (of a possible 9); these trials published faster (median time from trial completion to publication, 12.6 [interquartile range {IQR}, 6.7 to 23.3] vs. 21.8 [IQR, 12.1 to 34.9] months; P<0.01). They also had better normalized citation impact (median citation percentile for topic and date of publication, with 0 best and 100 worst, 1.92 [IQR, 0.64 to 7.83] vs. 8.41 [IQR, 1.80 to 24.75]; P=0.002). By random forest regression, we found that the 3 most important predictors of normalized citation percentile values were total costs, intention-to-treat analyses (as a modified Delphi quality measure), and focus on clinical (not surrogate) endpoints., Conclusions: NHLBI CV trials were more likely to publish results quickly and yield higher topic-normalized citation impact if they reported results according to well-defined metrics, along with focus on clinical endpoints., (© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

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., (Copyright © 2014 Mosby, Inc. All rights reserved.)

In recent years, a progressive increase in the number of medical diagnostic and interventional procedures has been observed, namely in cardiology. A significant proportion of them appear inappropriate, i.e. potentially redundant, harmful, costly, and useless. Recently, the document Medical Professionalism in the New Millennium: A Physician Charter, the American Board of Internal Medicine (ABIM) Foundation Putting the Charter into Practice program, JAMA's Less Is More and BMJ's Too Much Medicine series, and the American College of Physicians' High-Value, Cost-Conscious Care initiatives, have all begun to provide direction for physicians to address pervasive overuse in health care. In 2010, the Brody's proposal to scientific societies to indicate the five medical procedures at high inappropriateness risk inspired the widely publicized ABIM Foundation's Choosing Wisely campaign. As part of Choosing Wisely, each participating specialty society has created lists of Things Physicians and Patients Should Question that provide specific, evidence-based recommendations physicians and patients should discuss to help make wise decisions about the most appropriate individual care. In Italy, Slow Medicine launched the analogue campaign Fare di più non significa fare meglio. The Italian Association of Hospital Cardiologists (ANMCO) endorsed the initiative by recognizing the need to optimize available resources, reduce costs and avoid unnecessary cardiovascular assessments, thereby enhancing the more efficient care delivery models. An ad hoc ANMCO Working Group prepared a list of five cardiac procedures that seem inappropriate for routine use in our country and, after an internal revision procedure, these are presented here.

Recently, the American College of Cardiology Foundation in collaboration with the Heart Rhythm Society published appropriate use criteria (AUC) for implantable cardioverter-defibrillators and cardiac resynchronization therapy. These criteria were developed to critically review clinical situations that may warrant implantation of an implantable cardioverter-defibrillator or cardiac resynchronization therapy device, and were based on a synthesis of practice guidelines and practical experience from a diverse group of clinicians. When the AUC was drafted, the writing committee recognized that some of the scenarios that were deemed "appropriate" or "may be appropriate" were discordant with the clinical requirements of many payers, including the Medicare National Coverage Determination (NCD). To charge Medicare for a procedure that is not covered by the NCD may be construed as fraud. Discordance between the guidelines, the AUC, and the NCD places clinicians in the difficult dilemma of trying to do the "right thing" for their patients, while recognizing that the "right thing" may not be covered by the payer or insurer. This commentary addresses these issues. Options for reconciling this disconnect are discussed, and recommendations to help clinicians provide the best care for their patients are offered., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The environment in which the field of cardiology finds itself has been rapidly changing. This supplement, an expansion of a report created for the Board of Trustees, is intended to provide a timely snapshot of the socio-economic, political, and scientific aspects of this environment as it applies to practice both in the United States and internationally. This publication should assist healthcare professionals looking for the most recent statistics on cardiovascular disease and the risk factors that contribute to it, drug and device trends affecting the industry, and how the practice of cardiology is changing in the United States., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

With the increasing globalization of clinical research and evidence, clinical-practice guidelines (CPGs) developed by the European Union (EU) and the USA are also becoming increasingly international. However, these CPGs can encounter barriers to their practical application. In this Perspectives article, we analyze the main obstacles to the application of EU and US CPGs for cardiovascular diseases from the unique perspective of China, and highlight some potential problems in the globalization of CPGs. Currently, China and other countries with limited independent evidence for CPG development must localize or adapt the CPGs developed by the EU, the USA, or international medical organizations, with systematic consideration of cost-effectiveness and alternative strategies on the basis of the available evidence from the native populations. At the same time, comprehensive capabilities to collect and review clinical evidence to produce population-specific CPGs should be developed.

Rapid technological advances with enhanced clinical application have promoted the utility as well the growth of cardiac imaging. However, this has also raised concerns about over-utilization and inappropriate use in imaging. The imaging community, which initially took pride in increasing imaging volume, now fears limited access and reduced reimbursement. Nonclinicians, i.e., payers, have become gatekeepers to cardiac imaging, with decisions often lacking firm foundation within medical literature. The near-ubiquitous presence of radiology benefits managers is clearly impacting on the use of cardiac imaging, often through an indiscriminant reduction in imaging volume. Medical societies and clinicians were slow to respond to spiraling costs of cardiac imaging, but now recognize the need to promote appropriate and cost-conscious use of imaging. Through the development of guidelines and appropriateness criteria, physician-directed efforts are focused on eliminating unnecessary testing and promoting increased awareness of health care costs. This paper attempts to review some of the current issues concerning the responsible use of cardiovascular imaging.

The purpose of this article is to provide a comprehensive understanding of the business issues surrounding provision of dedicated cardiovascular computed tomographic imaging. Some of the challenges include high up-front costs, current low utilization relative to scanner capability, and inadequate payments. Cardiovascular computed tomographic imaging is a valuable clinical modality that should be offered by cardiovascular centers-of-excellence. With careful consideration of the business aspects, moderate-to-large size cardiology programs should be able to implement an economically viable cardiovascular computed tomographic service.

In the near future, the practice of cardiology in Europe will be strongly influenced by a complex interplay of epidemiological, social, economical, professional, and technological evolving factors. The present report summarizes the conclusions of an expert conference organized by the European Society of Cardiology to discuss the interactions between these phenomena, in an attempt to foresee the potential scenario in which cardiovascular healthcare and research will develop in the near future, and to anticipate solutions to the identified problems.

Based on the medical and economical data of 137 German hospitals including 12 university hospitals, the Institut für das Entgeltsystem im Krankenhaus (InEK) was again authorized by the German Ministry of Health to calculate and develop a refined version of the German diagnosis related groups (G-DRG) for the year 2004. The catalogue of these updated GDRGs was published on October 15' 2003. Furthermore, the grouper programs containing the current algorithms and the cost data on which the new G-DRGs were based have been published in the last few weeks. With regard to cardiovascular DRGs, a number of changes have been introduced in the G-DRG system which have profound consequences for all departments that treat patients with these diseases. In this review, we want to present in detail the key points of this update concerning the DRGs, extra reimbursement for special interventions, and new codes for diagnoses and procedures. Furthermore, the new rules for readmissions of patients in the same hospital are summarized. In conclusion, a number of improvements have been implemented in the updated G-DRG system which had in part been suggested by several national medical societies. These provide the basis for more precise and detailed DRGs but require on the other hand, a precise and complete coding to allow correct grouping procedures. From an economical point of view, it could hardly be summarized whether these improvements would lead to an adequate reimbursement for the treatment costs of patients with cardiovascular diseases since the case-mix of the various departments may vary widely.

Today, some 60 million individuals suffer from some form of cardiovascular disease, at a cost of +151 billion. Thirty-one billion dollars is spent on coronary artery bypass, angioplasty, and cardiac catheterization alone. Cardiology is being scrutinized by the government, payers and purchasers of healthcare.

The ACC has affirmed its commitment to universal access to health care. Underserved populations exist in urban and rural centers. Common to each is a paucity of personnel trained in cardiovascular care and a lack of access to preventive and highly technologic services. These factors contribute to a poor health outcome (75). Part of the rural problem can be corrected by the transfer of information to local providers by the use of new information systems. Included would be real-time electronic consultation, on-site subspecialty visits and the appropriate use of nonphysician providers (15). The urban problem requires changes in priorities and responsibilities of the academic health centers toward the communities they serve. Curricula changes of cardiovascular specialists, internists, generalists and nonphysician health care personnel must include diversity in training, physician training of ethnically matched providers in addition to technical excellence and research into methods of patient education and motivation for a healthier life-style (51). Reimbursement must appropriately reward those caring for underserved patients and those providing evaluation and management services (43,52).

The largest benefit of having a cardiac registry is quality. Everyone from patients, payers, physicians, and the public wants to know your quality...many hospitals are unprepared to answer these questions.