CMS Releases Proposed 2015 Medicare Physician Fee Schedule and Hospital Outpatient Rule The Centers for Medicare and Medicaid Services (CMS) on July 3 released two proposed rules with important ramifications for cardiovascular professionals. These rules address Medicare payment and quality provisions for physicians and hospital outpatient services in 2015. The rules indicate that physicians will see no change in payment for the first three months of 2015 due to the latest sustainable growth rate (SGR) patch. However, the SGR will take effect April 1, 2015, unless Congress once again intervenes. At that time physicians would face a 20.9 percent cut as a result of the legally mandated SGR. Hospitals will receive a 2.1 percent increase in payment for outpatient services. As in previous years, the ACC continues to fight to avoid cuts to Medicare payment for cardiovascular services. Aside from the across-the-board cuts associated with the SGR, CMS estimates that the physician rule will increase payments by 1 percent to cardiologists from 2014 to 2015. This estimate is based on typical practice and can vary widely depending on the mix of services provided in a practice. Some of the other most important proposals for cardiology contained in the rules include: Physician Fee Schedule • In response to an Office of the Inspector General report and other concerns about misvaluation of surgical services, CMS proposes to transition all 10- and 90-day global period codes to zero-day global periods starting in 2017. • CMS proposes policies to apply the value-based payment modifier to all physician and nonphysician eligible professionals. The agency also proposes to expand public reporting of clinical quality measures. • CMS would create a new code to report non-face-to-face chronic care management. This proposal caps a two-year effort to create a mechanism to pay physicians for managing complex patients and follows the 2013 implementation of transitional care management services that include non-face-to-face work. • In this proposed rule, CMS seeks review of 65 services with Medicare allowed charges of $10 million or more as a prioritized subset of codes under the newly established statutory category of “codes that account for the majority of spending under the physician fee schedule.” This list includes SPECT myocardial perfusion imaging, transthoracic echocardiography and stress echocardiography. • CMS proposes to delete the exception in the Physician Payments Sunshine Act for reporting of indirect payments by industry to physicians serving as faculty for accredited and/or certified continuing medical education. Hospital Outpatient Rule • The requirements for physician certification of inpatient admissions would be revised under this proposal to apply only for long-stay cases and costly outlier cases. CMS believes that in most cases, the admission order, medical record and notes contain sufficient information to support the medical necessity of an inpatient admission. • To better understand the effect of hospital-owned practices on payment trends, CMS proposes to create a Healthcare Common Procedure Coding System modifier to be reported with every code furnished in this setting beginning Jan. 1, 2015. • For 2015, CMS proposes to implement 28 Comprehensive Ambulatory Payment Classifications (APCs) after delaying them for 2014. Services assigned to the comprehensive APCs will be defined as primary services, with payment for all other services reported under a single hospital stay packaged under the primary service. • For 2017 and subsequent years, CMS proposes to remove three measures from the Hospital Outpatient Quality Reporting Program (OQR): OP-4: Aspirin at Arrival (National Quality Forum #0286), as well as two prophylactic antibiotic surgery measures. CMS considers these measures to be “topped out,” meaning that performance among hospitals is so high and unvarying that meaningful distinctions and improvements in performance can no longer be made. Hospitals that fail to meet the OQR reporting requirements will continue to face a payment reduction of 2 percentage points. Detailed summaries of these rules are available on CardioSource.org. The ACC will be submitting comments on the rules to CMS at the end of the summer. Sunshine Act Heats Up The Physician Payments Sunshine Act, also referred to as the Open Payments Program, requires public reporting by manufacturers of medical products and group purchasing organizations (GPOs) of all payments or transfers of value to physicians and teaching hospitals, as well as ownership or investment interests held by physicians or immediate family members of physicians in such manufacturers and GPOs. Reports of industry payments made between Aug. 1 and Dec. 31, 2013, will be released to the public on Sept. 30. Physicians and teaching hospitals have until Aug. 27 to preview and dispute information contained within the reports. After the close of the initial 45-day preview period, there is an additional 15-day period that physicians and teaching hospitals can use to continue to work with industry to resolve disputes. To preview your report, you must first register through the Centers for Medicare and Medicaid Services’ (CMS) Enterprise Portal, a system designed to verify your identity. Due to concerns with the registration and dispute resolution processes that have arisen in recent months, the ACC submitted recommendations to CMS in June. Health Care Community Fights for Stricter Regulation of E-Cigarettes and Other Tobacco Products Earlier this year, the U.S. Food and Drug Administration (FDA) proposed a new rule that would extend its authority to cover electronic cigarettes (e-cigarettes) and additional tobacco products. The extension is part of the Family Smoking Prevention and Tobacco Control Act passed in 2009, which granted the FDA authority to regulate tobacco products, such as cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. According to the proposal, the additional tobacco products that would be “deemed” to be subject to FDA regulation are those that meet the statutory definition of a tobacco product, including currently unregulated marketed products, such as e-cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe (or hookah) tobacco and dissolvables not already under the FDA’s authority. While this is a step in the right direction, the ACC and its allies do not believe that the proposal extends far enough and could undo any gains made at the federal and state level. In a fight to reduce tobacco-related deaths, the ACC, along with other health care organizations, recently submitted comments to the FDA. In addition to the College’s comments, a number of ACC chapters submitted letters calling for the FDA to strictly regulate e-cigarettes and other tobacco products. CMS Agrees to Create Interventional Cardiology Specialty Designation The Centers for Medicare and Medicaid Services (CMS) has developed a new specialty code in interventional cardiology to reflect its distinction from other specialties. The ACC supported a request from the Society for Cardiovascular Angiography and Interventions to obtain the new designation, which allows CMS to distinguish an interventional cardiologist from a clinical cardiologist when billing for Medicare services. Previously, no mechanism existed for CMS to accurately report on this category of physician and some local Medicare carriers have denied claims, citing duplicate billing, when a cardiologist and an interventionalist from the same group practice have billed for patient evaluation services. Once CMS takes necessary next steps to create a new code, it will allow for the reporting of the involvement of two specialty physicians providing distinct services to an individual patient. On the Horizon: New Issues Emerging in the States Throughout the year, the College’s State Advocacy team works with ACC chapters to advance legislation that enhances patient care and defeat bills that threaten cardiovascular professionals and patients. While legislative efforts around issues such as cardiopulmonary resuscitation/automated external defibrillators, imaging and pulse oximetry continue to dominate in the states, a number of new issues are emerging across the country that are likely to have an impact on the cardiovascular field. Here are a few issues on the horizon: • Intersection of clinical research, quality improvement and state health regulations: Increasingly, state health departments are relying on ACC’s guidelines, appropriate use criteria and quality initiatives to set rules for state policies. The College has been involved in several states to ensure the ACC programs are used to guide as opposed to creating policy. To date, the ACC has been successful at having ACC chapter leaders appointed to state health policy panels. • Energy drinks: State officials are proposing bills and regulations to ban marketing and sales to youth. Often these proposals are part of a broader effort to reform school nutrition programs. • Naturopaths: Naturopaths are alternative medicine “practitioners” who are advocating to perform many of the services, tests and diagnoses physicians are licensed to perform. They market themselves as “naturopathic physicians,” which many believe is misleading because they are not medical doctors or doctors of osteopathy. Currently, there are 17 states with boards that approve naturopathic licenses and set rules for their scope of practice. Education to Meet Action in the Nation’s Capital ACC’s efforts leading the transformation of care will be in the spotlight during the ACC’s 2014 Legislative Conference, which will take place Sept. 14 – 16 in Washington, DC. This year’s conference will provide the inside scoop on regulatory changes, legislative action and the state of cardiology to empower members to become effective advocates for patients and cardiovascular professionals. In addition to hearing first-hand from members of Congress, Capitol Hill staff and other policymakers who will provide an insider’s view of Washington, DC, attendees will have the opportunity to meet directly with congressional leaders to ensure the voice of cardiology is heard on Capitol Hill. To kick-off the conference, political power couple James Carville, America’s best-known political consultant, and Mary Matalin, one of the foremost conservative voices in America, will headline a special ACC Political Action Committee dinner. Visit CardioSource.org and search #ACCLegConf on Twitter in September for full coverage of the conference. FDA Approves Vorapaxar to Reduce Heart Attack and Stroke Risks in High-Risk Patients The U.S. Food and Drug Administration has approved vorapaxar (Zontivity) to reduce the risk for myocardial infarction (MI), stroke, cardiovascular-related death and coronary revascularization among patients who have previously experienced MI or peripheral artery disease. Vorapaxar is the first in a new class protease-activated receptor-1 (PAR-1) antagonist drugs and is designed to target thrombin-induced platelet activation. A 2011 clinical trial showed vorapaxar, added to other anti-platelet agents (generally aspirin and clopidogrel), reduced the rate of a combined endpoint of heart attack, stroke, cardiovascular death and coronary revascularization when compared to placebo. FDA Approves CoreValve for Patients at High Risk for Surgery The U.S. Food and Drug Administration (FDA) has granted accelerated approval of the self-expanding transcatheter CoreValve System for patients with severe aortic stenosis who are at high risk for surgery. The FDA gave its approval due to the positive results reported in the High Risk Study of the CoreValve U.S. Pivotal Trial, which compared transcatheter aortic valve replacement (TAVR) with the CoreValve System to traditional surgical aortic valve replacement, and “met its primary endpoint with high survival at one year for patients receiving the CoreValve System (85. 8 percent), which was statistically superior to patients receiving a surgical valve (80.9 percent).” According to David H. Adams, MD, FACC, professor and chair of the Department of Cardiothoracic Surgery at Mount Sinai Medical Center and co-principal investigator of the study, the trial was “the first prospective study of any device that suggests TAVR is superior to [surgery] in a predefined population of patients, and that’s a provocative finding.” He emphasized the “outstanding outcomes” in the surgical arm: “The low mortality rates with conventional surgery far exceeded the predicted mortality according to the Society of Thoracic Surgeons predictive model. In order to pass a superiority threshold, transcatheter treatment with the CoreValve device had to exceed excellent surgical outcomes.” The CoreValve System was previously approved by the FDA for patients at extreme risk in January 2014. ACC Shares Personalized Medicine and Telemedicine Insights on Capitol Hill ACC President Patrick T. O’Gara, MD, FACC, was invited to share his perspective on how personalized medicine can advance cures and treatments in the 21st century during a House Energy and Commerce Committee roundtable in July. The roundtable provided an opportunity for key players in health care to have an open discussion about the advancements and pitfalls of personalized medicine and discuss its role in improving patient care moving forward. The ACC also took part in a House Small Business Committee meeting on telemedicine last month. MARK YOUR CALENDARS! Physician Payments Sunshine Act report preview and dispute initiation period ends. After this date, physicians and teaching hospitals have an additional 15-day period to continue to work with industry to resolve disputes. Publication of Physician Payment Sunshine Act reports based on data from the last five months of 2013 Last day for first time participants to attest to successfully participating in the Electronic Health Records Incentive Program and avoid the 2015 penalty Last day to register Physician Quality Reporting System group-practice decisions around your reporting options
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