Intersection of Payer Coverage Policies and Clinical Care: Striking the Right Balance in Cardiovascular Medicine.

The US Food and Drug Administration (FDA) is a remarkable hybrid. Part regulatory agency, part public health agency, it sits at the intersection of science, law, and public policy. The FDA’s mission can be considered in the context of 2 broad dimensions: the products it regulates and its core functions. Both fall under the rubric of protecting and promoting the public health. The FDA’s remit is both broad and diverse: altogether, the agency has regulatory responsibility for >20% of the US economy. The products it is charged with overseeing through its various centers1 encompass food and cosmetics (regulated by the Center for Food Safety and Applied Nutrition); food and drugs for animals, including companion animals and animals used for food (regulated by the Center for Veterinary Medicine); and medical devices, drugs, and biologics (regulated by the Centers for Devices and Radiological Health, Drug Evaluation and Research, and Biologics Evaluation and Research, respectively). Tobacco products were added to the FDA’s portfolio by the Tobacco Control Act of 2009, and are overseen by the Center for Tobacco Products. Regardless of the specific product regulated, the FDA’s core mission remains the same: to protect the US population by helping to ensure the fundamental safety of the food Americans consume and the medical products prescribed by their clinicians. At the same time, this primary mission is complemented by a mandate to promote the public health by reviewing research and taking appropriate action on the marketing of regulated products in a timely manner. Not only do people need access to advances in nutrition and medical therapies, but also the American spirit is itself characterized by a strong current of scientific and technological innovation. At first glance, differences in these 2 priorities, protecting the public safety and promoting the public health through encouraging innovation, might …

Perioperative Medicine: What the Future Can Hold for Anesthesiology.

A Suicide-Specific Diagnosis – The Case Against

The goal of this paper is to provide an updated review for scientists and clinicians on the major areas in cardiovascular medicine published in the Journal. Leading topics in regenerative and personalized medicine are presented along with a critical overview of the field. New standards in large preclinical animal models of pulmonary hypertension and left bundle branch block are highlighted. Finally, clinical care in the areas of atherosclerosis, the aortic valve, platelet biology, and myocarditis is discussed as well as autonomic modulation therapies.

Wearable devices, such as smartwatches and activity trackers, are commonly used by patients in their everyday lives to manage their health and well-being. These devices collect and analyze long-term continuous data on measures of behavioral or physiologic function, which may provide clinicians with a more comprehensive view of a patients' health compared with the traditional sporadic measures captured by office visits and hospitalizations. Wearable devices have a wide range of potential clinical applications ranging from arrhythmia screening of high-risk individuals to remote management of chronic conditions such as heart failure or peripheral artery disease. As the use of wearable devices continues to grow, we must adopt a multifaceted approach with collaboration among all key stakeholders to effectively and safely integrate these technologies into routine clinical practice. In this Review, we summarize the features of wearable devices and associated machine learning techniques. We describe key research studies that illustrate the role of wearable devices in the screening and management of cardiovascular conditions and identify directions for future research. Last, we highlight the challenges that are currently hindering the widespread use of wearable devices in cardiovascular medicine and provide short- and long-term solutions to promote increased use of wearable devices in clinical care.

Article, see p 270 Biomarkers are clinical, molecular, or image-based measurable parameters that can characterize an individual’s specific biological state, whether normal, pathological, or in response to treatment. A biomarker is considered of clinically valuable if (1) it can be measured repeatedly with accuracy and relatively rapid clinical turnaround, (2) it provides unique, superior information on patient status, and (3) it aids in clinical decisionmaking with high precision.1 High-quality biomarkers can critically inform clinical diagnosis (eg, high-sensitivity troponin for acute myocardial infarction) and guide therapy (eg, CYP2C19 status for clopidogrel therapy). The ideal biomarkers can further reveal underlying biological processes, inform therapeutic deployment, and pave the way for true personalized precision medicine. In this issue of Circulation , Ngo et al2demonstrate the use of a developing proteomics technology to rapidly screen for protein biomarkers in patients with planned and spontaneous myocardial infarcts. How valuable are new, additional biomarkers in cardiovascular medicine? The current medical literature is replete with publications on biomarkers in cardiovascular medicine. A search of the PubMed database revealed 6421 articles on biomarkers and cardiovascular disease in 2015 alone. Unfortunately, despite the wealth of publications, truly high-value biomarkers that are etiologically specific, reproducibly validated in multiple populations, andinformative in decisionmaking, and that can be implemented in clinical care are very few indeed. As highlighted in the most recent guidance on personalized medicine for cardiovascular disease from the Food and Drug Administration, the need for high-value, validated biomarkers to guide treatment development is now more urgent than ever.3 Advances in systems biology over the past decade have provided more opportunities for innovative discovery of biomarkers than ever before. These advances range from identifying disease-causing genes using deep genome sequencing, the characterization of mRNA, microRNA, and noncoding RNAs through RNA-Seq, and profiling the expressed proteins and …

Circulation Research began 50 years ago, as I entered medical school in St Louis, and we have grown up together. I have luckily worked during a golden age for cardiovascular medicine, when biological and engineering sciences have prospered and greatly benefited our patients. This remarkable half-century testifies to the power of science to promote health. It is a vindication of the commitment my colleagues and I made to medical science so long ago and a tribute to the mission of Circulation Research . I will trace some of the scientific milestones, reflected by my Cardiology career. Having majored in history, I entered medical school in St Louis seriously deficient in science. I fortunately soon fell into the hands of Earl Sutherland, a physician who studied with Carl Cori and by 1952 was part of the Biochemistry faculty. He was trying to understand epinephrine action on glycogen metabolism, which subsequently led him to discover adenylyl cyclase and cAMP as the prototype “second messenger system,” winning the Nobel Prize in 1971. I worked half-time in his laboratory, purifying phosphorylase and absorbing his enthusiasm for science. During my second-year Pharmacology course, I was taught by Robert Furchgott, who received the Nobel Prize in 1998 for his work on nitric oxide. Medical school was exciting. During internship interviews with the prestigious Chairmen of Medicine, I was surprised that they grilled me on my research, not my clinical skills. So I returned to school and with two other students embarked on my first independent research effort to develop an antibody to lupus protein for immunolocalization. I collected plasma from a patient with severe systemic lupus erythematosus by withdrawing whole blood and returning packed red cells. Surprisingly, the patient immediately went into remission, possibly the first therapeutic plasmapheresis.1 Several supportive faculty provided the resources I …

Thomas H Lee. Published by Harvard University Press, 2013. Hardback, 400 pages. ISBN: 978-0674724976, £25.95. In this biography of one of the greatest leaders in modern cardiology, Thomas Lee places...

Education: “The process or art of imparting knowledge, skill and judgment; Facts, skills and ideas that have been learnt, either formally or informally.” — Wikipedia 1 The term profession is applied to those persons who have specialized and technical skill or knowledge which they apply, for a fee, to certain tasks that ordinary and unqualified people cannot ordinarily undertake. The term derives from the Latin: “to swear (an oath) …” . — Wikipedia 2 Let’s consider how we as cardiovascular medicine specialists spend our days in the care of people with cardiovascular disease. In the office or making rounds in the hospital, we prescribe drugs and order diagnostic tests; in the noninvasive laboratory, we obtain and interpret images of the heart; in the electrophysiology and cardiac catheterization laboratories, we program and implant devices in patients. When antithrombotic and fibrinolytic drugs are administered, and primary percutaneous coronary intervention is done using balloon catheters and intracoronary stents, lives are saved among patients with acute myocardial infarction. Response by Avorn and Choudhry see p 2221 The mortality risk from heart failure decreases and quality of life increases from the proper and appropriate use of angiotensin-converting enzyme inhibitors and β-blockers. Lipid lowering through the use of statin drugs saves lives and reduces serious cardiovascular complications such as myocardial infarction and stroke when properly prescribed to patients with a variety of manifestations of atherosclerotic vascular diseases. According to a recent publication by Ford and colleagues,3 deaths due to coronary heart disease in the United States declined substantially from 1980 to 2000, resulting in >340 000 fewer deaths in 2000. The authors attributed approximately half of this decline to changes in cardiac risk factors and half to the application of evidence-based therapies. An underlying theme in all of this is that the pharmaceutical, biotechnology, and …

Dialysis Access: At the Intersection of Policy, Innovation, and Clinical Care

ObjectiveThe aim of this study is to both quantify and qualify the way insurance companies justify their coverage policies for autologous chondrocyte implantation (ACI) and determine whether these policies align with recent research on the subject.DesignThe top 11 national commercial health insurance payers for ACI were identified. Coverage policy documents were recovered for 8 payers. These documents were examined, and the type of reference and the level of evidence (LOE) were recorded for each applicable reference. Specific coverage criteria for each individual payer were then extracted and assessed for similarities among commercial payers. Finally, all references cited by each payer were examined to determine whether they mentioned the specific payer criteria.ResultsThis study found that the majority of cited references were primary journal articles (86, 58.1%) and that only 30 (20.2%) references were level I or level II evidence. This study also found significant homogeneity among payer coverage criteria. Cited sources inconsistently mentioned specific payer coverage criteria. In addition, payer criteria tended to be poorly supported by current evidence on ACI.ConclusionsThis study demonstrates that commercial insurance payers’ coverage policies for ACI poorly cite references, cite a majority of references with low LOE, and cite references which infrequently mention their specific coverage criteria. In addition, payer coverage policies have a high degree of homogeneity and many of their specific criteria are poorly supported by current research on ACI.

Commentary on Vickers.

The National Heart, Lung, and Blood Institute (NHLBI) convened a Working Group on January 7, 2011, at George Washington University in Washington, DC, to provide recommendations to the NHLBI that would guide informed decisions on research directions and priorities in the field of cardiovascular

Artificial Intelligence in Cardiovascular Medicine: From Clinical Care, Education, and Research Applications to Foundational Models—A Perspective

HomeCirculationVol. 134, No. 18Hospitals of History Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBHospitals of History Joseph Hill, MD, PhD Joseph HillJoseph Hill Search for more papers by this author Originally published1 Nov 2016https://doi.org/10.1161/CIRCULATIONAHA.116.025698Circulation. 2016;134:1307Cardiovascular medicine of today is positioned atop a platform of robust history. Galen, Harvey, Bernard, Osler, Barnard, and Braunwald, to name a few, discovered principles of cardiovascular science and medicine that we too often take for granted. It goes without saying that we owe these giants a large debt of gratitude.It is sometimes easy to forget that these giants toiled in facilities of historical significance, buildings often with unique cultural identify and of great beauty. Some were of church, or even cathedral, style; others were more mundane. In times of war, our professional predecessors cared for the sick in truly barren circumstances. Our understanding of the history of our profession would be incomplete without appreciation of the clinical facilities in which our predecessors cared for the sick and unveiled novel insights.To document this history, we now reach out to cardiovascular societies around the world to submit high-quality images of their historical hospitals and clinics. We hope to feature images from around the globe, both from world centers and from more obscure corners. Some of these hospitals will be places of significant discovery; some, where clinical care was emphasized and practiced. We will select among the images and, when possible, publish them with a brief caption at the end of an article, in page space that would otherwise be unused. We expect that the majority of these images will be black and white, in which case there will be no page charge.With this initiative, we embrace our globally shared heritage of cardiovascular science. In addition, we will witness in pictorial form the unique beautify of clinical facilities around the world, and sometimes across centuries, from which our modern profession has emerged.FootnotesCorrespondence to: Joseph A. Hill, MD, PhD, Division of Cardiology, UT Southwestern Medical Center, 6000 Harry Hines Blvd, Dallas, TX 75390. E-mail [email protected] Previous Back to top Next FiguresReferencesRelatedDetails November 1, 2016Vol 134, Issue 18 Advertisement Article InformationMetrics © 2016 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.116.025698PMID: 27799255 Originally publishedNovember 1, 2016 PDF download Advertisement