Create a Value-Driven Health Care System • Ensure the successful implementation of the appropriate use criteria mandate included in the Protecting Access to Medicare Act of 2014, which empowers clinicians to manage the utilization of advanced imaging services through the clinical decision making process • Promote care coordination among the entire cardiovascular care team, in alignment with ACC’s team-based care health policy statement, particularly as it relates to care for patients with chronic conditions • Foster participation in alternative payment models and clinical practice improvement activities that support the delivery of evidencebased, high-quality patient care • Ensure appropriate implementation of the Medicare Access and CHIP Reauthorization Act of 2015 Promote the Use of Clinical Data to Improve Care • Promote the development of, and incentivize the use of, clinical data registries while ensuring relevant medical specialty society governance and oversight • Encourage the appropriate use and release of clinical data Ensure Patient Access to Care and Cardiovascular Practice Stability • Promote policies which would ensure appropriate payment for services in every setting • Defend the In-Office Ancillary Services Exception to the Stark Law, which recognizes that a referral within a group practice promotes continuity of care in a setting that is best for the patient • Continue to promote uptake and usability of electronic health records with an emphasis on interoperability to advance improvements in patient care • Promote the use of and payment for telemedicine services • Enact medical liability reforms that guarantee the protection of patients, improve provider-patient communications, and promote affordable and accessible liability protection, while adhering to successful reform efforts already in place at the state level Improve Population Health and Prevent Cardiovascular Disease • Ensure a healthy population through the regulation of tobacco and e-cigarettes Foster Research and Innovation in Cardiovascular Care • Ensure the future of the physician workforce by championing appropriate funding and distribution of graduate medical education • Advocate for additional funding for the National Institutes of Health, U.S. Food and Drug Administration and Centers for Disease Control and Prevention Learn more about ACC’s advocacy efforts at ACC.org/Advocacy. Don’t Miss ACC’s 2015 Legislative Conference Hundreds of ACC members from across the country will gather in Washington, DC, from Oct. 18-20 to advocate for cardiovascular professionals and patients. In addition to educational sessions on the hot button issues in health care, attendees will have the opportunity to meet directly with their legislators to share cardiology’s priorities. The conference will kick-off on Sunday with an ACC Political Action Committee (ACCPAC)-sponsored dinner and reception featuring Pulitzer Prize–winning syndicated columnist, political commentator and psychiatrist Charles Krauthammer, MD. A full day of educational sessions on Monday will delve into the latest developments in the American Board of Internal Medicine’s Maintenance of Certification program, new alternative payment models, grassroots advocacy efforts in the states, what the Medicare Access and CHIP Reauthorization Act of 2015 means for cardiology and legislative and regulatory issues on the horizon. On Tuesday, attendees will head to Capitol Hill to discuss how the decisions lawmakers make impact providers and patients nationwide. Learn more about the conference and the ACCPAC event at ACC.org/LegislativeConference. CMS Releases Proposed 2016 Medicare Physician Fee Schedule and Hospital Outpatient Rules In July, the Centers for Medicare and Medicaid Services (CMS) released the proposed 2016 Medicare Physician Fee Schedule, which addresses Medicare payment and quality provisions for physicians in 2016. Under the proposal, physicians will see a 0.5 percent payment increase on Jan. 1, 2016. Next year will be the first of several years of predictable payments resulting from the legislation that permanently repealed the Sustainable Growth Rate (SGR) this spring. CMS estimates that the physician rule will neither increase nor decrease payments to cardiologists from 2015 to 2016. This estimate is based on typical practice and can vary widely depending on the mix of services provided in a practice. CMS also released the proposed 2016 Hospital Outpatient Rule in July, which indicates a - 0.1 percent payment update for hospitals. Highlights from both rules include: PROPOSED: 0. 5 percent payment increase on Jan. 1, 2016 PHYSICIAN FEE SCHEDULE • This rule does not contain proposals to implement the new appropriate use criteria (AUC) requirement for advanced imaging services i.e., single-photon emission computed-tomography (SPECT) myocardial perfusion imaging (MPI), computed tomography and mitral regurgitation that begins Jan. 1, 2017. Rather, CMS provides information on the process that the agency will employ to: º Create the policies for identifying which AUC will be used in the program º Specify minimum standards for clinical decisions support tools º Identify potential priority clinical areas upon which to focus CMS will continue to work with the ACC and other stakeholders through the comment period to propose policies through future rulemaking. • CMS proposes to maintain most policies applicable to the Physician Quality Reporting System (PQRS) for the 2016 performance year. Under most individual reporting options, eligible professionals will continue to report at least nine measures across at least three domains. Failure to successfully report PQRS quality measures in 2016 will continue to result in a -2 percent payment adjustment in 2018. • Application of the Value-Based Payment Modifier on 2018 payments will be expanded to non-physician eligible professional solo practitioners and group practices (i.e., physician assistants, nurse practitioners and clinical nurse specialists) based on the 2016 performance period. Failure to report PQRS quality measures in 2016 will continue to result in a -2 percent payment adjustment in 2018 • CMS seeks review of 118 services with Medicare allowed charges of $10 million or more as a prioritized subset of codes under the statutory category of “codes that account for the majority of spending under the physician fee schedule.” This list includes SPECT MPI, transthoracic echocardiography, stress echocardiography, electrophysiology device monitoring services, and 3-D electrophysiology mapping. Proposed 2016 Hospital outpatient rule: -0.1 percent payment update for hospitals • CMS invites informational comments on how best to implement the Merit-based Incentive Payment System created by the Medicare Access and CHIP Reauthorization Act of 2015, legislation that fixed the SGR. The program takes effect in January 2019 and will be based upon data collected during 2017. CMS specifically requests feedback on which activities should fit the definition of clinical practice improvement and how to set a low-volume threshold to exclude eligible providers who would not have adequate data to use for payment adjustments. Additional topics and questions will be made regarding alternative payment models through future requests for information. • CMS is proposing a number of changes to the physician self-referral (Stark) regulations “to accommodate delivery and payment system reform, to reduce burden, and to facilitate compliance.” In addition to attempting to address comments received in response to the Self-Referral Disclosure Protocol issued in 2010, CMS is particularly interested in the effects of the Stark regulations on the ability to achieve the clinical and financial integration needed for health care delivery and payment reform. For 2016, CMS proposes to implement nine new Comprehensive APCs (C-APCs), including one new C-APC for comprehensive observation services. HOSPITAL OUTPATIENT RULE • CMS does not propose payment policy changes for services associated with short hospital inpatient stays of less than two midnights. It does outline changes to its existing “rare and unusual” exceptions policy to allow Part A payment on a case-by-case basis for inpatient admissions that do not satisfy the two-midnight benchmark. Additionally, CMS proposes to make use of Quality Improvement Organizations to educate doctors and hospitals about Part A payment policy for inpatient admissions. Certain restrictions on Recovery Audit Contractors’ review of admitting decisions will also be implemented. These include changes to the “look-back period,” limits on additional documentation requests and requirements for timely reviews. • CMS continues its policy to package payment for items and services that are integral, ancillary, supportive or adjunctive to a primary service. For 2016, CMS proposes to expand the list of packaged ancillary services to include Level 4 Minor Procedures such as cardiac drug stress tests and electrocardiogram monitoring and reporting up to 48 hours. CMS also proposes to package payment for two drugs (bivalirudin and abciximab) into the Ambulatory Payment Classification (APC) payment for percutaneous coronary intervention procedures. • For 2016, CMS proposes to implement nine new Comprehensive APCs (C-APCs), including one new C-APC for comprehensive observation services. This would provide payment for all services received during a non-surgical encounter with a high level outpatient hospital visit and eight or more hours of observation. For 2017 and subsequent years, hospitals that fail to meet the requirements of the Hospital Outpatient Quality Reporting Program will receive a 2 percent reduction to their annual fee schedule update factor. • For 2017 and subsequent years, hospitals that fail to meet the requirements of the Hospital Outpatient Quality Reporting Program (OQR) will receive a 2 percent reduction to their annual fee schedule update factor. CMS also proposes to align the OQR with the Ambulatory Surgical Center Quality Reporting Program. Detailed summaries of these rules are available at ACC.org/Advocacy. The College is in the process of soliciting feedback from member groups and will submit comment letters to CMS at the end of the summer. Updated Pacemaker Implantation Coding Requirements Consistent with the updated national coverage determination that took effect in 2013, the Centers for Medicare and Medicaid Services (CMS) has issued updated coding requirements for pacemaker implantation. Starting July 6, claims for these services are only processed when the KX modifier is included on the claim line as attestation by the provider of the service that documentation is on file verifying the patient has non-reversible symptomatic bradycardia due to sinus node dysfunction, second degree and/or third degree atrioventricular block. Some indications for implantation such as pacemaker syndrome or congenital long QT syndrome are not explicitly addressed in coverage. Other indications, such as “medication-induced” bradycardia, are non-covered despite inclusion in guidelines and comments to CMS during the coverage development process. In these instances, CMS has recommended that providers communicate directly with local Medicare contractors to obtain additional guidance. Thorough documentation will be especially important in these instances. ACC Emerging Advocates Program Launches As part of ACC’s commitment to leadership development, the College has launched the Emerging Advocates Program. This program is a unique opportunity for ACC members, particularly Fellows in Training, Early Career Professionals and Cardiovascular Team members, to increase their knowledge of, and participation in, the College’s legislative, regulatory, state government relations, payer advocacy and value solutions, and population health efforts. During the two-year program, the Emerging Advocates will learn directly from the College’s advocacy leaders and identify opportunities where they can advance ACC’s advocacy activities. The ACC welcomes the following members as the first class of Emerging Advocates: Justin M. Bachmann, MD, MPH, FACC Julie M. Clary, MD, MBA Sarika K. Desai, DO Warren Q. Foster, MD Osvaldo S. Gigliotti, MD, FACC Olivia N. Gilbert, MD Sunny Jhamnani, MD Aaron P. Kithcart, MD, PhD Sandeep Kumar Krishnan, MD Mohan A. Kumar, MD Jason S. Reingold, MD, FACC Heather M. Ross, DNP Sheila Sahni, MD Pascha E. Schafer, MD, FACC Maria Spinelli, NP ACC Advocacy Action on Meaningful Use In May, the ACC submitted comments to the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) on the proposed rule for Stage 3 of the Electronic Health Record (EHR) Incentive Program, also known as Meaningful Use. In its comments, the ACC recognized CMS and ONC’s efforts to ease the constraints and complexities established in Stages 1 and 2 of the program and their attempt to further clarify EHR certification. However, “Overall, the ACC believes the proposed requirements for Stage 3 set the bar for success too high.” In separate comments to the Senate Committee on Health, Education, Labor and Pensions, the College called for a delay of Meaningful Use Stage 3, and provided recommendations related to vendor data blocking, effective EHR standards, post-certification surveillance of EHR systems and the reevaluation of the Health Insurance Portability and Accountability Act and security of data. The ACC also submitted comments to CMS on the proposed rule for aligning Stage 2 of the EHR Incentive Program with the proposed Stage 3 rule. The ACC applauded CMS for proposing changes that will benefit providers and patients alike, such as aligning all program participants to reporting on the calendar year, providing for a 90-day reporting period in 2015, and reducing program complexities. “The modifications proposed lay a framework for progress towards a program structure that allows for the broad adoption and improved use of health information technology leading to interoperable health information exchange.” National Youth Tobacco Survey Shows Popularity of E-Cigarettes in Teens While cigarette use in middle and high school students decreased from 15.8 percent to 9.2 percent between 2011 and 2014, the use of hookah and electronic cigarettes (e-cigarettes) went up significantly, according to the results of the 2014 National Youth Tobacco Survey, co-conducted by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration (FDA). In 2014, 24.6 percent of high school students reported using a tobacco product, while 12.7 percent reported current use of two or more products. E-cigarettes were the most popular tobacco product in both middle and high school, with 3.9 percent use and 13.4 percent use, respectively. Compared to 2011, e-cigarette use in high school students is up 11.9 percent, with hookah use increasing from 4.1 percent to 9.4 percent between 2011 and 2014. “Tobacco-related products have continued to evolve at a pace faster than our scientific understanding of their biological effects,” stated Pamela B. Morris, MD, FACC, chair of ACC’s Prevention of Cardiovascular Disease Section Leadership Council, in response to the survey results. “Despite claims of potential health benefits, the long-term consequences of adolescent exposure to electronic cigarette aerosol, which contains nicotine, carbonyls (formaldehyde and acrolein) and particulates, are unknown.” The FDA is currently finalizing a rule that would extend its authority to regulate e-cigarettes, cigars and hookahs. 21st Century Cures Legislation Gains Momentum The House of Representatives on July 10 passed legislation that would provide significant new funding for the National Institutes of Health (NIH) and streamline the U.S. Food and Drug Administration’s (FDA’s) regulatory process – modernizing clinical trials and medical product regulation – to support the development of innovative cures. H.R. 6, the 21st Century Cures Act, earned broad bipartisan support and passed the House by a 344 – 77 vote. “The increased mandatory funding for the NIH drives home the importance of innovation and medical research, and the health care community’s efforts to improve patient outcomes through new treatments,” said ACC President Kim Allan Williams Sr., MD, FACC. The U.S. has long been a leader in medical research that has advanced patient care throughout the world. Our health care system – and more importantly our patients – can’t afford for us to become stagnant. This legislation helps address that need.” The key provisions of H.R. 6 are as follows: • Incorporate the patient perspective in the discovery, development and delivery process • Increase funding for the NIH and FDA, both through reauthorization and over $9 billion in mandatory funding over five years, starting in FY 2016 • Foster development of treatments for patients facing serious or life-threatening diseases • Repurpose drugs for serious or life-threatening diseases and conditions • Modernize clinical trials • Break down barriers to increase collaboration and data sharing among patients, researchers, providers and innovators • Support the development of personalized and precision medicines so the right patient can receive the right treatment at the right time • Provide for continued work in the telehealth space • Advance a truly interoperable health care system • Provide clarity for developers of software products used in health management and medical care The House Energy and Commerce Committee, which drafted the original bill, noted that it has “done things differently with 21st Century Cures.” The legislation is the result of months of bipartisan efforts to solicit feedback from “every corner of the health care innovation infrastructure.” The ACC had a chance to provide insight into health care innovation when ACC Immediate Past President Patrick T. O’Gara, MD, MACC, shared cardiology’s perspective during a roundtable discussion on personalized medicine last summer. The College has also submitted two rounds of comments on the first discussion draft to help guide the Committee as it refined the proposal. The legislation will now move to the Senate, where the outlook is still unclear. The ACC will continue to help shape the future of health care by working with Congress on important concepts included in 21st Century Cures. ACC Brings Together Experts to Discuss Population Health and Primary Prevention The ACC recently hosted a retreat to help shape the College’s Population Health Policy agenda. The meeting convened ACC members and a diverse array of experts from government agencies, universities, medical specialty societies and private sector partners to discuss primary prevention, health equity and social determinants of health, the changing health care landscape, and the role of primary care professionals in advancing cardiovascular health. Speakers from the Centers for Disease Control and Prevention, Centers for Medicare and Medicaid Services, CVS Health, Harvard Medical School, U.S. Department of Health and Human Services (HHS) – including Karen DeSalvo, MD, MPH, Msc, acting assistant secretary for health at HHS – Walmart, the White House and more, talked about how their organizations are making strides in reducing heart disease. During the keynote address, Valentin Fuster, MD, PhD, MACC, shared his views about why cardiologists must go the extra mile by working with partners to change the landscape and improve patient health through the lifespan. Moving forward, the discussions will be used to create the College’s Population Health agenda. The agenda – which will include elements of primary and secondary prevention and specific goals and targets related to diet, nutrition and exercise – will be presented later this year to the Board of Trustees. Stay tuned for more information. ACC Testifies on Health Information Blocking at Senate HELP Committee Hearing In July, Michael J. Mirro, MD, FACC, testified at a Senate Health, Education, Labor, and Pensions Committee (HELP) hearing titled “Achieving the Promise of Health Information Technology: Information Blocking and Potential Solutions.” Mirro, a member of the ACC’s Informatics and Health Information Technology (IT) Task Force, shared cardiology’s perspective on the important issue of health information blocking, unforeseen problems that have been created by electronic health records (EHRs), and possible solutions to help improve care. During his testimony, Mirro stressed that transparency of additional (or hidden) fees within EHR vendor contracts should be evaluated; data fluidity should mean not only that information reaches the provider, but that the data is transmitted quickly and securely; EHR vendors’ products should be universal and connect to other EHRs offered by different companies; and health IT vendors and providers should be incentivized to establish networks for patients to monitor their devices, empowering them to actively participate in their health decisions. “Rapid, secure exchange of health information is critical and in some cases can mean the difference between a patient living and dying,” Mirro underscored to the Committee. Mirro also echoed ACC’s earlier recommendation that Meaningful Use Stage 3 be delayed in its entirety, especially since only 11 percent of physicians have attested to Stage 2. “The HITECH Act, along with implementation of the Meaningful Use Program, has improved data sharing and data liquidity. With that stated, the unintended consequence of Meaningful Use is that systems were designed to facilitate charge capture and revenue cycle management and focus less on clinical data and usability,” he said. “Although the Meaningful Use program has brought favorable results within the context of data transfer, many of the requirements set forth in the program are unattainable.” In a press conference following the hearing, Senate HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) announced they are officially asking the U.S. Department of Health and Human Services Secretary Sylvia Burwell to delay Stage 3. ACC Advocacy has been working hard to elevate the health IT concerns of ACC members on Capitol. This testimony is one part of a multi-pronged strategy to ensure that the ACC is a leader in the discussion on the success of EHRs. ICD-10 is Coming! Are you ready for Oct. 1, 2015? Get Access to Cardiology Codes • 2016 Code Books Online at CMS.gov/ICD10 • Check Chapter 9 (Diseases of the Circulatory System) for cardiology codes Review Changes For Cardiology AMI codes • Take note of changes for AMI • MI is broken down by type (STEMI or NSTEMI), site and time parameter (initial, subsequent or old) • Review the aftercare codes Secondary Diagnosis Codes Use additional codes to identify: • Exposure to environmental tobacco smoke (Z77.22) • History of tobacco use (Z87.891) • Occupational exposure to environmental tobacco smoke (Z57.31) • Tobacco dependence (F17.-) • Tobacco use (Z72.0) Hypertension codes • There is no hypertension table in ICD-10 • Review individual and combination hypertension codes Afib and Atrial Flutter Codes Located in category I48 and coded to type: • Paroxysmal/intermittent atrial fibrillation (I48.0) • Persistent atrial fibrillation (I48.1) • Chronic/permanent atrial fibrillation (I48.2) • Typical/type 1/common atrial flutter (I48.3) • Atypical/type II atrial flutter (I48.4) Two unspecified codes: • Unspecified atrial fibrillation (I48.91) • Unspecified atrial flutter (I48.92) *These codes, with the specificity of the codes above, should rarely be used FDA Approves New Heart Failure Drug The U.S. Food and Drug Administration on July 7 approved Novartis’ Entresto (sacubitril/valsartan) to treat chronic heart failure. The drug is usually taken with other heart failure treatments and replaces angiotensinconverting enzyme inhibitors and other angiotension receptor blockers. In the PARADIGM-HF study, Entresto was shown to reduce the risk of cardiovascular death and heart failure hospitalization as compared to the angiotensin-converting enzyme inhibitor enalapril. Side effects of the drug include hypotension, hyperkalemia and renal impairment. “The FDA’s approval of Entresto (sacubitril/valsartan), a first-in-class combined angiotensin receptor neprilysin inhibitor, is a major advance in systolic heart failure care,” said Sean Pinney, MD, FACC, editorial team lead of the ACC.org Heart Failure and Cardiomyopathies Clinical Topic Collection, and director of the Advanced Heart Failure & Cardiac Transplant Program at Mount Sinai Medical Center in New York, NY. “The approval was supported by the successful outcome of the PARADIGM-HF trial, which showed meaningful reductions in heart failure hospitalization, cardiovascular death and all-cause mortality compared to the angiotensin converting enzyme inhibitor enalapril. The use of a run-in phase and underrepresentation of certain populations has led to appropriate concerns about hypotension and angioedema, especially in African Americans. Lingering questions about pricing and its appropriate positioning in the clinical guidelines will be addressed in the months ahead.” FDA Approves First of Novel Cholesterol-Lowering Drugs The U.S. Food and Drug Administration (FDA) on July 24 approved Sanofi and Regeneron Pharmaceuticals’ Praluent (alirocumab) injection, the first lipid-lowering drug in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors. The approval comes just a little over a month after the FDA Endocrinologic and Metabolic Drugs Advisory Committee recommended two PCSK9 inhibitors for approval. The new class of drugs has the potential to offer millions of patients with high low-density lipoprotein cholesterol (LDL-C) an alternative treatment option to statins, which are associated with numerous side effects. The FDA has approved the treatment for patients with familial hypercholesterolemia (FH) or clinical atherosclerotic cardiovascular disease in conjunction with maximally tolerated statin therapy and diet modification. The agency notes that itching, swelling, pain or bruising at the injection site, nasopharyngitis and flu are common side effects of the PCSK9 injection treatment. PCSK9 is a protein that controls LDL-C levels in the blood by regulating LDL receptor metabolism. Since a 2006 study first suggested that impaired PCSK9 activity might lower cardiovascular events, numerous clinical trials have been underway to study PCSK9 inhibitors. The results of two trials looking at alirocumab and Amgen’s evolocumab were presented at ACC.15. Results from the OSLER-1 AND - 2 Trial showed the use of evolocumab plus standard therapy dramatically lowered LDL-C. The study found patients receiving evolocumab saw their cholesterol drop 61 percent, from a median of 120 mg per deciliter to 48 milligrams per deciliter. Reductions were sustained through the median 11-month follow-up period. The ODYSSEY LONG TERM trial found that among patients with heterozygous FH or high cardiovascular risk, alirocumab resulted in a large reduction in LDL-C compared with placebo, which was maintained, although slightly attenuated at 78 weeks. Alirocumab appeared to be generally well-tolerated and was associated with low cardiovascular events. While results showing the drugs’ effectiveness at lowering LDL-C are promising for the new agents, definitive evidence showing the effectiveness of the drugs for reducing cardiovascular risk won’t be available until 2017 when large clinical trials are completed. “The ACC eagerly awaits the results of the clinical trials that are in progress,” said ACC President Kim Allan Williams, Sr., MD, FACC. “In the meantime, we continue to recommend physicians limit prescribing to the very high risk, hard-to-treat groups approved by the FDA and otherwise follow the current guidelines, which recommend lifestyle change and, if needed, statins for most patients with or at risk of heart disease. Improving diet and optimizing exercise are the cornerstones of heart disease management and prevention. Statins are available as low-cost generics, are well tolerated in most patients, and their effectiveness is supported by strong evidence.”
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