European Heart Journal (2013) 34, 3525–3530 doi:10.1093/eurheartj/eht455

Cardiologists urged to reduce inappropriate radiation exposure Radiation from cardiology procedures equals more than 50 chest X-rays per person each year Cardiologists have been urged to reduce patient radiation exposure in a European Society of Cardiology (ESC) position paper that outlines doses and risks of common cardiology examinations for the first time.

Reference 1. PicanoE, Van˜o´ E, Rehani MM, Cuocolo A,Mont L, BodiV, Bar O, MacciaC, PierardL, SicariR, Plein S, Mahrholdt H, Lancellotti P, Knuuti J, Heidbuchel H, Di Mario C, Badano LP. The appropriate and justified use of medical radiation in cardiovascular imaging: a position document of the ESC Associations of Cardiovascular Imaging, Percutaneous Cardiovascular Interventions and Electrophysiology. Eur Heart J 2013; 10.1093/eurheartj/eht394 (in press).

Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2013. For permissions please email: [email protected]

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The full paper, entitled ‘The appropriate and justified use of medical radiation in cardiovascular imaging: a position document of the ESC Associations of Cardiovascular Imaging and Percutaneous Cardiovascular Interventions’, was published in European Heart Journal (EHJ).1 The lead author, Dr Eugenio Picano (Pisa, Italy), said: ‘Cardiologists today are the true contemporary radiologists. Cardiology accounts for 40% of patient radiology exposure and equals more than 50 chest X-rays per person per year’. He added: ‘Unfortunately, radiation risks are not widely known to all cardiologists and patients and this creates a potential for unwanted damage that will appear as cancers, decades later. We need the entire cardiology community to be proactive in minimising the radiological friendly fire in our imaging labs’. The paper lists doses and risks of the most common cardiology examinations for the first time. CT, PCI, cardiac electrophysiology, and nuclear cardiology deliver a dose equivalent to 750 chest X-rays (with wide variation from 100 to 2000 chest X-rays) per procedure. PCI for dilation of coronary artery stenosis totals almost 1 million procedures per year in Europe. The additional lifetime risk of fatal and non-fatal cancer for one PCI ranges from 1 in 1000, to 1 in 100 for a healthy 50-year- old man. Risks are 1.38 times higher in women and 4 times higher in children. Dr Picano said: ‘Even in the best centres, and even when the income of doctors is not related to number of examinations performed, 30 to 50% of examinations are totally or partially inappropriate according to

specialty recommendations. When examinations are appropriate, the dose is often not systematically audited and therefore not optimised, with values which are 2 to 10 times higher than the reference dose’. The paper aims to reduce the unacceptably high rate of inappropriate examinations and reduce excessive doses in appropriate examinations. Dr Picano said: ‘In these hard economic times, 50% of the costly and risky advanced imaging examinations we do are for inappropriate indications’. He added: ‘Decreased doses can best be accomplished by working with industry and many companies are now successfully fighting a “dose war”. Companies who develop better ways of reducing doses will win in the future global competition. Radiological sustainability is becoming a competitive marketing advantage’. The paper says that patients should be given the estimated dose before a procedure and the actual dose in writing afterwards if they request it. This could become a legal requirement through the European Directive Euratom law 97/43, but application of the law is being delayed by technical and practical difficulties. Dr Picano said: ‘Patients can protect themselves by not selfprescribing screening examinations promoted by irresponsible advertisers. Second, before any testing they should ask their doctor what is the likely radiation dose they will get from that examination. After the exam they should receive the true delivered dose in a written report, which may differ by a factor of 10 from the theoretical reference dose’. He added: ‘The smart patient, and the smart cardiologist, cannot be afraid of radiation since it is essential and often lifesaving. But they must be very afraid of radiation negligence or unawareness. This paper will help to make cardiology wards and laboratories a safer place for patients and doctors through an increase of radiation awareness and knowledge’.

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doi:10.1093/eurheartj/eht397 Online publish-ahead-of-print 17 September 2013

Moving from political declaration to action on reducing the global burden of cardiovascular diseases: a statement from the Global Cardiovascular Disease Taskforce

----------------------------------------------------------------------------------------------------------------------------------------------------------Keywords

AHA Scientific Statements † Cardiovascular diseases † Metrics † Non-communicable diseases † Prevention † Global cardiovascular disease

18 September 2013 marks 2 years since the monumental meeting of Heads of State at the United Nations in New York to take action against non-communicable diseases (NCDs), which include cancer, cardiovascular disease (CVD), diabetes mellitus, and chronic respiratory disease. Recognizing that the rising human and financial costs of NCDs required a profound shift in the way countries viewed development, United Nations member states gathered for the second time in history to address a health concern (the first being the United Nations General Assembly Special Session on HIV/AIDS in 2001). Supporting the United Nations Political Declaration on the Prevention and Control of NCDs, countries acknowledged NCDs as a development issue and made a commitment to address this global crisis by taking action on the major modifiable risk factors—including tobacco use, raised blood pressure, poor nutrition, and physical inactivity—triggering the new pandemic of NCDs, as well as the social, economic, and political determinants that shape these lifestyle choices.1 Although the declaration was a political commitment, it was an important first step, bringing together health and development leaders from across the globe to ensure that progress would be made to reduce the burden of NCDs. The past 2 years have witnessed concrete commitments, meaning that our work is only just beginning. The World Heart Federation and its members spearheaded global advocacy, with other colleagues in the NCD community, calling on the

World Health Organization and member states to commit to tangible and achievable goals.2 In 2012, a global target was adopted to reduce premature NCD mortality by 25% by 2025—‘25by25’.3 Now in 2013, this target, as well as eight additional targets addressing modifiable risk factors and committing to the use of essential medicines, technologies, and drug therapies to prevent heart attacks and strokes, has been adopted as part of a global monitoring framework and included in the World Health Organization’s Global Action Plan for the Prevention and Control of NCDs (see Supplementary material online).4,5 These collective decisions taken by governments and ministers of health have ensured that a global architecture is in place that requires governments to be accountable for the actions they take to address NCDs in their countries. This is an extraordinary time of opportunity for the CVD community. As we move from political aspiration to practical application, what role can the CVD community play in developing and implementing a coordinated international strategy of action to attain these fundamental goals for the health of nations? At global level, the adoption of this architecture—a global monitoring framework with 9 ambitious targets and 25 indicators— means that governments, for the first time, are accountable for progress on NCDs. These commitments will be translated into action at national level through strong and cost-effective national plans. Each of our professional organizations will advocate and offer

The World Heart Federation, American Heart Association, American College of Cardiology Foundation, European Heart Network, and European Society of Cardiology make every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all the members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest. This document was approved by the World Heart Federation, American Heart Association Science Advisory and Coordinating Committee, American College of Cardiology Foundation Board of Trustees, European Heart Network Board, and European Society of Cardiology Board in August 2013. This article has been copublished in Global Heart, Journal of the American College of Cardiology, and Circulation. Copies: This document is available on the World Wide Web sites of the World Heart Federation (www.world-heart-federation.org), American Heart Association (http://my. americanheart.org), American College of Cardiology Foundation (www.cardiosource.org), European Heart Network (www.ehnheart.org), and European Society of Cardiology (www.escardio.org). A copy of the document is available at http://my.americanheart.org/statements by selecting either the ‘By Topic’ link or the ‘By Publication Date’ link. To purchase additional reprints, call 843-216-2533 or e-mail [email protected]. Expert peer review of AHA Scientific Statements is conducted by the AHA Office of Science Operations. For more on AHA statements and guidelines development, visit http://my. americanheart.org/statements and select the ‘Policies and Development’ link. *The writing committee members represent the following participating organizations: World Heart Federation (S.C.S., A.C., D.C.), American Heart Association (M.J., R.L.S.), American College of Cardiology Foundation (J.G.H., W.A.Z.), European Heart Network (S.J., S.L.), and European Society of Cardiology (P.E.V., D.A.W.)

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Writing committee*: Sidney C. Smith Jr (Chair), Amy Collins, Deborah Chen, John G. Harold, Mariell Jessup, Staffan Josephson, Cand Jur, Susanne Logstrup, Ralph L. Sacco, Panos E. Vardas, David A. Wood, and William A. Zoghbi

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NCDs, non-communicable diseases; WHF, World Heart Federation.

solutions that can be implemented nationally to address these targets. System change is not limited to systems that address health. As the world develops a framework to eradicate poverty and to reassesses the Millennium Development Goals, further progress will depend on recognizing that determinants outside health services affect the health of populations and patients. How people live, move, work, and eat is of paramount importance, and interventions to reduce exposure to modifiable risk factors, as well as address the underlying social determinants, must be planned and implemented now to protect future generations. The changes we are seeing in models of care in high-income countries towards controlling upstream determinants of NCDs must be expanded. Even the most advanced healthcare systems need to improve how they address primordial and primary prevention through change in population behaviour across the life span. Acknowledging that health systems in low- and middle-income countries have been built around infectious disease, these systems must now transform to address CVD morbidity and mortality. Tackling the growing burden of NCDs requires not only a whole of government approach but also a whole of society approach involving nongovernmental organizations, local communities, and industry, where appropriate. The CVD civil society community of heart and stroke foundations and societies across the globe must have a leading role in the implementation of national NCD plans and ensure a focus on CVD primordial, primary, and secondary prevention and rehabilitation. Sharing best practices, aligning measurements, fostering expertise, advancing implementation strategies, and providing leadership are critical and feasible measures to ensure that we achieve the ‘25by25’ target, not only for NCDs, but also for CVD (Figure 1).6 The Global Cardiovascular Disease Taskforce—comprising the World Heart Federation, American Heart Association, American College of Cardiology Foundation, European Heart Network, and European Society of Cardiology, and expanded representation from Asia,

Africa, and Latin America along with global CVD experts—is helping to sharpen our collective efforts to address CVDs. Working with the World Health Organization, we are assessing and defining those specific metrics for addressing CVD that will be key to achieving the global target of ‘25by25’. These metrics will extend beyond health systems and will be essential to preventing premature mortality. As CVD organizations operating with and through the World Heart Federation, which itself represents .200 organizations across the globe, and as partners to the World Health Organization, we are committed to the following: (1) Developing and publishing metrics around the ‘25by25’ target that are specific to CVD and tailored by geography by 2014. (2) Shaping and supporting inclusion of CVD language in national plans. (3) Coordinating and aligning efforts around implementation of the CVD-related targets under the ‘25by25’ global target, with a particular focus on reducing tobacco use and hypertension and improving secondary prevention and rehabilitation of CVD. As we move forward together as professional societies and heart foundations, let us be the global advocates, speaking with one voice, calling for CVD prevention, treatment, and care. We celebrate the Political Declaration of ‘25by25’ and its aspiration to reduce the burden of NCDs, and we now face the challenges of ensuring its reality and ensuring that government plans turn to action to improve the health of all of our populations.

Supplementary material The online-only Appendix is available with this article at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIR.0b013e3182a93504/-/DC1. Disclosure: P.E.V. has received honoraria from Bayer, Servier, Boehringer Ingelheim, Menarini, and Pfizer, and is on the advisory board for Respicardia. D.A.W. has received honoraria from AstraZeneca

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Figure 1 Reducing cardiovascular disease through a World Heart Federation by a global target of 25% by 2025.6 CVD, cardiovascular disease;

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(modest), Kowa (modest), and MSD (modest). He is a consultant for MSD. The remaining authors submitted disclosure forms for this statement and have indicated ‘None’.

References 1. United Nations General Assembly. Resolution adopted by the General Assembly: 66/2: Political Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases. Adopted 19 September 2011; published 24 January 2012. 2. Smith SC Jr, Collins A, Ferrari R, Holmes DR Jr, Logstrup S, McGhie DV, Ralston J, Sacco RL, Stam H, Taubert K, Wood DA, Zoghbi WA. Our time: a call to save preventable deaths from cardiovascular disease (heart disease and stroke). Circulation 2012; 126:2769 –2775. 3. World Health Organization. Sixty-Fifth World Health Assembly Resolutions, Decisions, Annexes. WHA65/2012/REC/1. May 21 – 26, 2012; Geneva,

Switzerland. http://apps.who.int/gb/or/e/e_wha65r1.html. (accessed 11 August 2013). 4. World Health Organization. Draft comprehensive global monitoring framework and targets for the prevention and control of noncommunicable diseases: Formal Meeting of Member States to conclude the work on the comprehensive global monitoring framework, including indicators, and a set of voluntary global targets for the prevention and control of noncommunicable diseases. A/NCD/INF./1. November 5– 7, 2012; Geneva, Switzerland. http://apps.who.int/gb/ncds/. (accessed 11 August 2013). 5. World Health Organization. Sixty-sixth World Health Assembly: Follow-up to the Political Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of Non-communicable Diseases. WHA66.10, Agenda item 13.1 and 13.2. May 27, 2013; Geneva, Switzerland. http://www.who.int/nmh/ events/ncd_action_plan/en/. (accessed 11 August 2013). 6. World Heart Federation. 25 by 25. http://www.world-heart-federation.org/ what-we-do/advocacy/25-by-25/. (accessed 29 August 2013).

An overview of the US Patient Protection and Affordable Care Act of 2010

Great Seal of the USA

On 23 March 2010, with the ink of 22 pens, President Barack Obama signed into law the Patient Protection and Affordable Care Act (ACA)1—a historic overhaul of the US healthcare system whose ripple effects are felt by virtually every US citizen. The new law dramatically changes the healthcare landscape through provisions to (i) expand health insurance coverage, (ii) improve the quality and efficiency of healthcare delivery, and (iii) control rising costs. While the ACA was and remains controversial in the USA, the law has survived substantial challenges including multiple repeal attempts by Congress, a dramatic Supreme Court case, and the November 2012 national elections that were seen by many as a referendum on the healthcare law. Yet, much hard work has been ongoing with implementing this complex law, and its ultimate impact on outcomes and costs remains uncertain. We briefly review the key provisions of the ACA for the readers of the EHJ with particular attention to aspects relevant for the cardiology community.

Health insurance coverage expansion At the time the ACA was being written into law, 49.1 million Americans (16.2% of the population) lacked healthcare insurance.2

President Barack Obama signing Patient Protection and Affordable Care Act into law The three major sources by which Americans have traditionally received health insurance are through their employer, Medicare for people over age 65 and those with some disabilities, and Medicaid, which is primarily for low-income adults, their children, and some young people with disabilities. Uninsured Americans could seek emergency care without being turned away or receive routine care on their own, but had to pay for services out of their own pockets and often at inflated rates. For many, the costs of medical bills could be overwhelming and healthcare expenses were responsible for over 60% of individual bankruptcies.3 Not surprisingly, these costs often meant that the uninsured would forgo needed preventive and chronic disease management care, and this contributed to their poorer health.4,5 The ACA expands health coverage through several mechanisms that address these challenges and is estimated to provide insurance to an additional 33 million Americans by 2019.6 The individual mandate requires that all Americans have health insurance, and provides a range of tools and assistance to make that feasible, even for low-income individuals. Firstly, insurance exchanges are being established by states, the federal government, or through state–federal partnerships to allow individuals to purchase affordable health insurance. These

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The new US Healthcare Law

doi:10.1093/eurheartj/eht455

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Quality and efficiency A landmark 2001 Institute of Medicine report documented the shortcomings in the quality of care delivered in the USA, and charted a course for improvement.9 Despite these gaps in care, the USA spends nearly twice as much on healthcare as other countries.10 Through both new programmes and pilot efforts within Medicare, the ACA seeks to improve the quality of healthcare while simultaneously controlling expenditures through more efficient care. The law creates several initiatives that are incentives for hospitals to coordinate and improve care. Hospital payments are now linked to quality performance metrics, such as the number of hospital re-admissions within 30 days for certain conditions and preventable hospital-acquired conditions. Given their high prevalence, morbidity, and mortality, acute myocardial infarction and congestive heart failure figure prominently in the hospital incentives, making these programmes relevant for cardiologists. The ACA also establishes similar incentive programmes in other healthcare settings outside of the hospital and will also link physician payments to both the quality of care they provide and the costs associated with their care. Furthering efforts to break down the silos between acute care hospitals, post-acute care services, and ambulatory care, the ACA established the Medicare Shared Savings Program. Within the programme, Accountable Care Organizations (ACOs) take responsibility for the overall care of ‘populations’ of patients, coordinate care across different providers, and invest in infrastructure and care delivery

redesign efforts. Accountable Care Organizations that achieve quality standards and lower costs share in the accrued savings. The Center for Medicare and Medicaid Innovation (CMMI)11 has a range of pilot projects seeking similar goals of care coordination to improve quality and control costs, including bundled payments for procedures such as coronary stenting. If successful, these CMMI programmes can be scaled up nationally and will transform healthcare delivery in the USA. Several initiatives aiming to improve both medical care and broader community health target cardiovascular disease. Medicare beneficiaries now receive US Preventive Services Task Force12 recommended screenings free of charge, such as for testing for hyperlipidaemia and hypertension. The newly established Prevention and Public Health Fund provides $5 billion in the first 5 years towards prevention research, health screenings, and interventions, which could be used for such efforts as community-based smoking cessation programmes. The Million Hearts campaign13 seeks to prevent 1 million heart attacks and strokes by 2017 through an emphasis on aspirin for high-risk individuals, blood pressure control, cholesterol management, and smoking cessation. Lastly, the ACA established the Patient-Centered Outcomes Research Institute,14 which will provide $4 billion through 2019 for better-informed decision-making.

Controlling costs The health spending portion of the US gross domestic product in 2010 was 17.9%—in other words, nearly 1 in 5 dollars earned in the national economy was spent on healthcare.15 While more recent evidence has shown a slowing in that growth rate, the reasons for this remain controversial and the large, continued health-related expenditures necessitate ongoing efforts to ‘bend the cost curve’. In addition to the many quality and efficiency programmes mentioned above, the ACA has a range of provisions specifically aimed at lowering Medicare payments and seeking to reduce waste, fraud, and abuse. The over-riding hope, however, is that programmes like ACOs and the CMMI pilots will transform the existing fee-for-service healthcare delivery model into one of greater accountability where providers simultaneously provide high-quality appropriate care and limit excess costs. The ultimate effects of these programmes on the long-term trajectory of healthcare costs are still unknown but will be critical for judging the ultimate impact of the ACA.

Remaining challenges and conclusion The ACA presents a uniquely American approach to healthcare reform. Although it is broad in scope, it represents several incremental changes within the framework of a private, market-based, health insurance system. Lessons drawn from international experience have clearly influenced the law and provide concepts that can potentially inform future policy-making. For example, the individual mandate for insurance coverage has been applied previously in European healthcare systems, such as Switzerland, where government subsidies also exist for low-income individuals to purchase health insurance. Yet it is important to remember that there are also many controversial areas that were left largely unaddressed by the ACA. For instance, future health reform efforts in the USA will need to address the controversial Medicare physician payment

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exchanges attempt to merge pools of individuals to create marketplaces where rates are similar to those received by bigger businesses. They went live for enrollment in October 2013, with insurance becoming active from 1 January 2014— a major implementation milestone for the new law. Secondly, businesses with 50 or more full-time employees will be required to offer health insurance, or face a penalty. While this requirement was set to take effect in January 2014, the implementation has been postponed by 1 year to allow employers more time to comply with the law. Employers with 25 or fewer employees can receive tax credits to support providing insurance. Thirdly, the ACA provides for Medicaid coverage for low-income individuals to be extended to adults with incomes of up to 133% of the federal poverty level. However, the 2012 Supreme Court ruling on the ACA made this Medicaid expansion optional for states to institute, and as of July 2013, 24 states, including the District of Columbia, are moving ahead with expanding Medicaid, 21 are not, and 6 states are continuing to debate the question.7 Fourthly, low-income individuals who do not qualify for the Medicaid expansion benefit will be able to receive sliding scale federal financial support to purchase insurance in the exchanges. Finally, in addition to the direct coverage expansion, the ACA implements a variety of private insurance reforms that make it easier and less expensive for people to obtain and keep health insurance. Insurers are prohibited from imposing lifetime limits on healthcare costs, charging higher premiums based on individual characteristics except age, geography, family size, and tobacco use, and denying insurance based on pre-existing conditions. Dependent children up to the age of 26 can now receive insurance through their parents— a provision already enacted that has led to more than 3 million additional people receiving insurance.8

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Conflicts of interest: W.B.B. does work with the US Department of Health and Human Services. His work on this paper was conducted through Weill Cornell Medical College and is not related to the Department of Health and Human Services.

Timeline of major Affordable Care Act implementation milestones

ACA, Patient Protection and Affordable Care Act; PCORI, Patient-Centered Outcomes Research Institute; CMMI, Center for Medicare and Medicaid Innovation.

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methodology (known as the Sustainable Growth Rate) and the medical malpractice system. It is also possible that more drastic efforts to control costs will be enacted as entitlement spending and rising budget deficits continue to raise concerns in Congress. However, the current attention is and should be focused squarely by providers and policy-makers on the upcoming year (2014), when the core elements of the ACA begin to take effect and millions more Americans will feel the security of having health insurance—some for the first time in their adult lives. For newly insured individuals, this will mean being able to obtain preventive care, manage chronic conditions, and treat acute disease without the fear of staggering financial debt. For the medical community and cardiologists, this will mean removing many of the socioeconomic barriers to providing the best care for our patients. For all Americans, full implementation of the ACA will mean reforms aimed at improving their individual health and the health of the medical system as a whole.

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References

8. Sommers BD, Buchmueller T, Decker SL, Carey C, Kronick R. The affordable care act has led to significant gains in health insurance and access to care for young adults. Health Aff (Millwood) 2013;32:165 –174. 9. Medicine Io. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001. 10. Organisation for Economic Co-operation and Development (OECD). http://www. oecd-berlin.de/charts/health/health-spending-gdp?cr=oecd&lg=en (Accessed 12 August 2013). 11. The Center for Medicare and Medicaid Innovation (CMMI). http://innovation.cms. gov/ (Accessed August 12, 2013). 12. US Preventive Services Task Force Prevention Recommendtions. http://www. uspreventiveservicestaskforce.org/recommendations.htm (Accessed 12 August 2013). 13. Million Hearts. http://millionhearts.hhs.gov/index.html (Accessed 12 August 2013). 14. Patient-Centered Outcomes Research Institute (PCORI). www.pcori.org (Accessed 12 August 2013). 15. Martin AB, Lassman D, Washington B, Catlin A. Growth in us health spending remained slow in 2010; health share of gross domestic product was unchanged from 2009. Health Aff (Millwood) 2012;31:208 – 219.

CardioPulse contact: Andros Tofield, Managing Editor. Email: [email protected]

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1. Patient protection and affordable care act. 2010;2010. 2. Martinez ME, Cohen RA. Health insurance coverage: early release of estimates from the National Health Interview Survey, January –June 2010. National Center for Health Statistics. December 2010. Available from: http://www.cdc.gov/nchs/ nhis.htm (Accessed 10 October 2013). 3. Himmelstein DU, Thorne D, Warren E, Woolhandler S. Medical bankruptcy in the United States, 2007: results of a national study. Am J Med 2009;122: 741 –746. 4. O’Hara B, Caswell K. Health Status, Health Insurance, and Medical Services Utilization: 2010. Current Population Reports. Washington, DC: U.S. Census Bureau; 2012, p 70 –133. 5. Chen J, Rizzo JA, Rodriguez HP. The health effects of cost-related treatment delays. Am J Med Qual 2011;26:261 –271. 6. CBO and JCT’s Estimates of the Effects of the Affordable Care Act on the Number of People Obtaining Employment-Based Health Insurance. Congressional Budget Office. March 2012. Available from: www.cbo.gov (Accessed 10 October 2013). 7. Status of State Action on the Medicaid Expansion Decision, as of July 1, 2013. Kaiser Family Foundation. http://kff.org/medicaid/state-indicator/state-activityaround-expanding-medicaid-under-the-affordable-care-act/ (Accessed 12 August 2013).

Cardiologists urged to reduce inappropriate radiation exposure.

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