Dr. Fuster Goes to Washington, Speaks on Global Health Recommendations The Global Health and the Future Role of the United States report was recently published by the National Academies of Sciences, Engineering, and Medicine (NASEM). It examined the changing landscape of global health to advise the U.S. government, as well as non-governmental organizations and the private sector, so as to improve their responsiveness, coordination and efficiency. Valentin Fuster, MD, PhD, MACC, editor-inchief of the Journal of the American College of Cardiology, served as co-chair of the committee that produced the report. He sat down with Cardiology to share its key messages. Why was it important that NASEM lead the effort to produce this report to inform the U.S. government and others about global health issues? The United States has a tremendously important role in these efforts, contributing more than $10 billion annually. The U.S. government’s dedication over the years has resulted in many successful, ongoing initiatives, including the President’s Emergency Plan for AIDS Relief and the President’s Malaria Initiative. The objective with this document was to examine the most pressing health needs globally and provide strategic direction for governmental investment over the next 20 years. It is important to remember that we cannot live in isolation, as the health and well-being of other countries both directly and indirectly affect the health, safety and economic security of Americans. Are noncommunicable diseases a focus of this report? This is one of four priority areas in the report. Noncommunicable diseases (NCDs), such as cardiovascular disease, chronic obstructive pulmonary disease and lung cancer, result in 40 million deaths globally each year, almost 75 percent of which are in low- and middle-income countries. The costs of managing these diseases are rising, with cardiovascular disease alone projected to cost the world $1 trillion annually for treatments and productivity losses by 2030. Many health systems in these countries are not adequately equipped to care for patients with NCDs, due to an historical focus on infectious diseases. Thus, our committee called for the United States Agency for International Development, the U.S. State Department and the Centers for Disease Control to support improved mobilization and coordination of private partners at the country level to implement strategies targeting cardiovascular disease risk factors, early detection and treatment of hypertension and cervical cancer, and immunization against cancer-causing viruses, such as human papillomavirus and hepatitis B. The cost of health care is under tremendous scrutiny. How does the report mitigate these concerns? To maximize the return on investment, while achieving better health outcomes, the report makes three recommendations to the U.S. Government: • Catalyze innovation through accelerated development of medical products and integrated digital health infrastructure • Employ more flexible financing mechanisms to leverage new partners and funders in global health • Maintain the status and influence of the U.S. as a world leader in global health while adhering to evidence-based science and economics, measurement and accountability. What are the next steps toward implementation? We presented the report to the U.S. Congress and our hope is that Congress and the presidential administration will incorporate our recommendations into health policy and programs going forward. ADVOCACY BRIEFS Approved! The Centers for Medicare and Medicaid Services (CMS) has finalized its national coverage decision (NCD) of supervised exercise therapy for symptomatic peripheral artery disease (PAD) patients with intermittent claudication (IC). IC patients will be eligible for up to 36 sessions during a 12-week period. The final coverage reflects suggestions made by the ACC and other organizations regarding supervision, site of service, session sequencing and amputation in response to the proposed NCD issued in March. The coverage is effective immediately, but it will take several months for CMS to issue guidance for providers to submit claims and guidance for Medicare Administrative Contractors to process those claims. Know Your Numbers As part of efforts to fight medical identity theft, the Medicare Access and CHIP Reauthorization Act requires CMS to remove Social Security Numbers (SSNs) from all Medicare cards by April 2019. Beginning in April 2018, CMS will start mailing Medicare cards with new Medicare Beneficiary Identifiers (MBIs) to all Medicare recipients. The new MBIs will replace the SSN-based Health Insurance Claim Numbers for transactions like billing, eligibility status and claim status after a transition period. More information on how to prepare is available in the Advocacy section of ACC.org. Appropriations Update On June 2, the College submitted written testimony to the U.S. Senate Appropriations Labor, Health and Human Services, Education and Related Agencies Subcommittee outlining all ACC appropriations requests for Fiscal Year 2018 (FY ‘18), including recommendations for the National Institutes of Health and Centers for Disease Control and Prevention (CDC), as well as the CDC Office on Smoking and Health, and congenital heart disease research funding. Given the budgetary climate and uncertainty surrounding the future of non-defense discretionary funding, these requests focus on programs most closely aligned with ACC’s mission. Scan the QR code for details. FDA Addressing Concerns Over Drug Shortages Over the last several weeks, cardiologists have reported increasing concerns related to ongoing shortages of sodium bicarbonate, epinephrine and dextrose. To address the shortage of sodium bicarbonate, the U.S. Food and Drug Administration (FDA) has approved importation of the drug from an Australian supplier for as long as necessary. To ensure patient safety, providers are encouraged to review manufacturer information highlighting the differences between the U.S. registered product and the imported version posted on FDA.gov. On the epinephrine front, the FDA says the emergency epinephrine syringe shortage is the result of a problem in the supply chain for one of the two domestic manufacturers of the drug. Because one domestic manufacturer does not have the capacity to replace the production capacity of the other and the FDA has not been able to identify a foreign source of the product, the agency is working with the manufacturer to identify solutions. At present, the FDA is advising providers to: • Consider drawing epinephrine from vials. While this is not an ideal solution, there are existing supplies of epinephrine in vials that should assist in alleviating the shortage. • Maintain supplies of expired emergency epinephrine syringes. The FDA is working with the manufacturer to determine if the expiration dates can be extended. Information will be posted online if such a determination is made. Additionally, the FDA is working with the dextrose manufacturer to determine whether those expiration dates can be extended as well. In both the epinephrine and dextrose situations, tables will be made available that identify affected product lot numbers, original expiration dates and new expiration dates to address any compliance issues that may arise from retaining expired lots. ACC will continue communications with the FDA on this important issue until the shortages are resolved. Scan the QR code to visit the FDA website detailing current and resolved drug shortages and steps the agency is taking to address them. The Informatics and Health Information Technology Task Force: Building Solutions Long before the Affordable Care Act, and even before President George W. Bush’s 2004 pledge for widespread implementation of the electronic health record, a group of cardiologists within the ACC were concerned about the impact of health information technology (IT) on cardiovascular professionals. First, under the leadership and guidance of James Dove, MD, MACC, then Michael Mirro, MD, FACC, and more recently James Tcheng, MD, FACC, the Informatics and Health Information Technology Task Force has been advising ACC leadership on navigating the treacherous currents of health IT that today affects all members. John Windle MD, FACC, and Jeff Westcott MD, FACC, are the current chair and co-chair of the Task Force. Health informatics is the interdisciplinary study of the design, development, adoption and application of IT-based innovations in health care services delivery, management and planning. Stated simply, the role of the Task Force is to help determine how to use health IT to make clinical care, quality, education and research easier for ACC members. It begins with advocacy. The Task Force works with government agencies such as the Centers for Medicare and Medicaid Services, Office of the National Coordinator and National Quality Forum, and other standards organizations such as the Cardiology Domain of Integrating the Healthcare Enterprise and medical societies to build bridges and identify and solve common health IT problems. The Task Force also serves a critical function working within the ACC to break down silos. A major challenge being addressed is registry reporting. Under exploration: How can data be captured at the point of care and transmitted to NCDR registries without needing a person to manually “abstract” the data from sources like EHRs? The Task Force is working with the Digital Steering Committee and the Guidelines Committee to leverage NCDR data when developing quality measures, appropriate use criteria and clinical guidelines. The Task Force is also looking at ways to support and enhance patient-centered care through its work with appropriate ACC committees. The implementation of health IT has created pain points. It is cited as a major cause of physician burn out by increasing administrative data collection and documentation, decreasing clinical efficiency for providers and creating new barriers to patient and team communications. Health IT is affecting the whole cardiology team. Nursing documentation is perhaps even more rigorous than physicians. A cadre of data abstraction specialists is now required to move digital data from one site to the next. Documentation tasks have taken precious time away from all providers, impacting the direct patient care experience and provider satisfaction. Thankfully, the ACC has a well-earned reputation as a leader and innovator in health IT. The Informatics and Health Information Task Force can see the light at the end of the tunnel, and is committed to minimizing health IT obstacles that separate cardiovascular professionals from their patients. CV Quality Corner Survey Highlights Challenges With Managing CV Risks in Patients With Diabetes It’s no secret that patients with diabetes are at increased risk of heart disease, heart failure and stroke. Additionally, diabetes can lead to high blood pressure and increased cholesterol. Managing these increased cardiovascular risks in patients with diabetes is fast becoming a topic of discussion in the cardiology space. A recent ACC survey found that more than four out of five cardiologists (81 percent) agree that cardiologists should play a larger role in addressing cardiovascular risks in their patients with diabetes. This perception was strongest among general cardiologists than those in more specialized areas of cardiology, like interventional cardiology or electrophysiology. The challenge lies in how to go about doing this. Several important randomized trials (i.e., EMPA-REG, SUSTAIN-6 and LEADER) show medical interventions in cardiovascular patients with diabetes can provide protective benefits. However, results from the CardioSurve survey suggest more needs to be done to raise awareness of these trials and their outcomes. Specifically, nearly 70 percent of survey respondents said they were not familiar with these trials. Of those who were aware, about one out of four (25 percent) were familiar with the EMPA-REG results, 21 percent were familiar with LEADER, and only 14 percent were familiar with SUSTAIN-6. Similarly, knowledge of these trials alone has been slow to bring about practice change. Only about one out of five cardiologists familiar with any of these trials said they have changed how they treat their patients. The most common change was more active recommendations to patients and/or their primary care physicians or endocrinologists about these new drugs and their potential to lower cardiovascular risks. “I include a recommendation in the letter to the referring primary care physician that there may be a survival advantage to the use of newer agents in the treatment of patients with CAD and T2D,” said one survey respondent. “Despite cost concerns they may wish to prescribe alternate or additional medication.” “With the new data, we all need to get up to speed,” says Christopher P. Cannon, MD, FACC, in a recent ACC.org video talking about the recent trials and their potential benefits. “As cardiologists we feel that we want to provide that cardiovascular protection. But how do we do that? We haven’t managed diabetes.” He stresses the importance of creating more dialogue between primary care, endocrinologists and cardiologists, noting that the cardiovascular profession has undertaken similar dialogue and partnerships around the use of dual antiplatelet therapy and cholesterol therapy. “There’s room for a really good partnership,” he says. In his recent “Eagle’s Eye View” podcast, Kim A. Eagle, MD, MACC, editor-in-chief of ACC.org, discusses the cardiovascular effects of the SGLT-2 class of drugs, illustrating “that as we get into a whole new world in terms of managing diabetes and cardiometabolic disease, especially as these drugs affect cardiovascular outcomes, cardiovascular specialists are going to have to be more and more comfortable both prescribing them and following patients with them.” World Health Organization statistics show the global prevalence of diabetes among adults has risen from 4.7 percent in 1980 to 8.5 percent in 2014. Worldwide, the number of people with diabetes has risen from 108 million to 422 million during this same period. Whether it’s developing patient education resources, leveraging data from the Diabetes Collaborative Registry to identify and capture key learnings and best practices from cardiovascular innovators, or holding its first “Managing CV Disease Risk in Diabetes Roundtable,” the College is focused on helping its members to best manage the cardiovascular risks associated with this increasing number of people with diabetes. The roundtable, which will take place in June, is designed to address the recent trial evidence for new antidiabetic drugs, their demonstrated improved cardiovascular outcomes and what that means for the cardiology community. Participants will address the key questions facing clinicians and work towards identifying solutions to overcome the gaps in knowledge and barriers to care. Scan the QR code for a video featuring Christopher Cannon, MD, FACC. Scan the QR code to read expert analysis on the 2017 American Diabetes Association (ADA) Standards of Medical Care in Diabetes. CardioSmart Corner Martha Gulati, MD, MS CardioSmart Editor-in-Chief Let’s Change History! Encourage Clinical Trial Participation While it would be great if everything we learn from clinical research could be applied to everyone, in reality, cardiovascular disease and many other conditions are not the same across sexes, age groups and racial and ethnic groups, and neither are their responses to treatment. Statistics show that women, along with racial and ethnic minorities, are more vulnerable to developing cardiovascular diseases and continue to lag behind when it comes to health outcomes. African Americans, for example, tend to have higher rates of diabetes, obesity, high blood pressure and untreated high cholesterol. They also have the highest rates of heart disease. When compared with men, women are less likely to survive a first heart attack, and young women have the poorest outcomes after a heart attack. The list goes on. So what’s behind these trends? New clinical trial resources posted to CardioSmart highlight several factors that may contribute to the health disparities among sex and racial/ethnic groups, including the fact that few research studies are designed to look specifically at heart and vascular diseases in women, and among racial and ethnic minorities. Additionally, more than half of trials for coronary heart disease over a decade failed to enroll any patients over 75 years old. Patient concerns also factor into these trends, including lack of trust in research studies and fear of unintended consequences. Cultural values and beliefs, as well as patient access to preventive care or specialty centers can also play a role. On the physician front, awareness about the different risks in patient populations is a major factor. Minority leadership is also an issue. For example, only one percent of all principal investigators supported by the National Institutes of Health are African American. Clinical trials pave the way for new and better therapies for many – but not necessarily all. In recent years, the U.S. Food and Drug Administration has called for broader representation of people of different ages, races, ethnic groups and sex in clinical trials. As cardiovascular professionals, on the front lines with patients, we can help facilitate this effort. Not only can we help raise awareness among ourselves about disparities in care, we can talk with our patients about clinical trials as options for treatment. We also have opportunities to encourage the next generation of researchers to take on leadership roles. Together we can improve care for everyone! Talk to Your Patients About Clinical Trials It’s important to talk with your patients about whether a clinical trial may be (or may become) a treatment option. Here are some questions to help guide your conversations with patients: • Is a clinical trial the right option given the medical history and prognosis? • How do they find a clinical trial that might benefit them? • How long will the study last? •What are the benefits? • What are the risks? • What are the costs? Visit CardioSmart.org/ClinicalTrials for an overview of clinical trials to help patients understand what they are and how they work and resources for finding a clinical trial for their condition.
Published by American College of Cardiology. View All Articles.
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