Edward T. A. Fry 2017-01-25 12:06:48
MACRA: How to Prepare For the Unknown Repeal of the Sustainable Growth Rate (SGR) formula and passage of the Medicare Access and CHIP Reauthorization Act (MACRA) in 2015 are proof that what might seem both impossible and improbable can happen. However, let’s face it, even those closest to the process and those in positions of leadership in the medical community know very little about what is to come with the actual launch of MACRA. We have never been here before. The rules are still being written. Implementation and interpretation vary from practice to practice, hospital to hospital, and system to system. Yogi Berra’s prediction about predictions will hold true: “It’s tough to make predictions, especially about the future.” What do we know? • MACRA, or at least the concept of tying reimbursement to outcomes (or measures), is here to stay. Though being rolled out initially through the Centers for Medicare and Medicaid Services, this concept will be agnostic to the type of payer (public, private, single, commercial, voucher system, etc.). There is no going back. • MACRA is, first and foremost, about controlling total cost. Like SGR, it is designed to slow, reverse, and then limit the growth of total expenditures through Medicare, Medicaid and the Children’s Health Insurance Program, which accounts for the majority of health care spending in the U.S (and about two-thirds of cardiovascular care). If one totals the amount of deferred spending cuts amassed from the beginning of SGR in 1997 and compares it to the minimal “adjustments” called for in MACRA, combined with anticipated inflation, it is a wash. Total public spending on health care will decline about 20 percent over the next 10 years relative to inflation and commensurate with the anticipated growth in number of recipients, based on current eligibility (which itself is likely to change). • MACRA, in reality, is not about “volume to value.” The winners in MACRA will be those providers, institutions and systems that provide care, no matter what arrangement, to the largest number of people. Bigger accountable care organizations will generate more revenue than smaller ones. Orthopedists doing more total joints in bundles will make more money than those doing fewer. • MACRA is really a system to define “sliding scale” reimbursement and redistribution of available funds to cover care based on achieving pre-specified metrics that may or may not reflect true clinical quality. These metrics are certainly intended to represent “value” and to be surrogates for efficiency and enhanced process of care. As we are learning, some of these metrics, such as chronic heart failure 30-day readmissions, may have a paradoxical, negative impact on actual quality of care. • MACRA will determine economic winners and losers along a continuum. There is not a “threshold” for receiving better reimbursement. The pie is baked; the slices will all add up to one full pie, not more. • MACRA will change the economic calculus of health care finances at the provider, hospital and system level. Somewhat counterintuitively, not all winners will be providing the best care and not all losers will be delivering sub-standard care. For example, a system that “over-invests” in staff, technology and other infrastructure to achieve 100 percent of all measures for all providers, without careful planning and detailed financial information, may actually lose money when compared with another system that invests more strategically and may actually reach fewer targets. This “paradox” might be illustrated by two similar systems: Both may deliver the same actual quality of care, but one may have documented it more thoroughly than the other, or one may have focused on what they believe to be more important components (e.g., mortality), rather than other metrics (e.g., 30-day readmissions), or one may have over-spent to build their MACRA process. Beware of unintended consequences. There are other examples of this concept of over-preparation and under-performance. When one looks at return on investment for Meaningful Use and for Value-Based Payment (VBP), there are many examples of practices and systems being financially upside-down. However, the goal of global electronic health record (EHR) adoption and VBP are still the right things to do and likely will have longer term benefits. Nonetheless, perfection may be the enemy of good. All parties will be looking for the Goldilocks “just right” balance between the costs associated with complying vs. the rewards of doing so. • MACRA is not a cardiology-specific initiative. No doubt, cardiovascular medicine is an important component, as reflected in the proposed metrics and in the portion of all patients receiving cardiovascular care, but it is by no means the main driver. MACRA is still predominantly a primary care-centric incentive plan. Health systems, practices and hospitals that put all their chips on cardiology services alone, at the expense of developing efficient, accessible, high-quality integrated primary care networks, will not be successful. However, the house of cardiology, and especially the ACC, is probably best prepared for this paradigm shift, because of the long-standing commitment to quality metrics, science, evidence based medicine, registries and clinical practice guidelines. • MACRA will be the vehicle through which the majority of us will receive our care as we age over the next decade, given the average age of cardiologists is 56. • MACRA will evolve and be tweaked, but its core essence will be retained. We must be nimble enough to change with it and to be engaged enough to influence that change (on behalf of patients, not necessarily ourselves). How do we prepare for the unknowable, to be successful in MACRA? • Take great care of patients! Use clinical practice guidelines, appropriate use criteria and evidence-based tests and treatments. This is what we do best and where we as clinicians can have the greatest impact. For some, there is an immediate urge to throw up our hands and wilt at the intimidating complexities of MACRA; however, this is one thing we can immediately and instinctually do to succeed in the new MACRA world order. • Document, document, document! Encourage health information technology (IT) vendors to build and configure EHRs to do much of this for us faster, better and cheaper! • Participate in (all) registries. • Focus on true process improvement: Measure, benchmark, get to the root cause, implement change, re-measure. Rinse and repeat. Focus on real descriptors of quality of care and end points that are meaningful to patients, not just “scorecard” checkboxes. • Innovate and be adaptable. Fellows in Training and early career professionals are already showing us how to do this. Follow their lead. Challenge IT to provide useful tools to be successful. • Go to meetings like ACC’s Cardiovascular Care Summit, Annual Scientific Session, Legislative Conference, etc. Read extensively outside the traditional clinical literature (read the clinical literature as well). Make what is going on in health care reform a part of the day-to-day conversation at your institution. Become a student of MACRA. • Embrace and develop multidisciplinary, integrated teams of care and service lines for all specialties. Learn from each other within cardiology and learn from other specialties. Orthopedists have much to teach us about delivering high-quality care within bundled payments. • Do not be afraid to make mistakes, but recognize failure quickly and learn from those mistakes. • Remove barriers to access. See more patients. Leverage the whole cardiovascular team to do this. • Make all operational and strategic decisions patient-centric. we will see what 2017 brings with respect to MACRA! The good news is that the Cubs won their first World Series in 108 years in 2016 – another seemingly impossible and improbable event. I like to think there is a little bit of each Cubs’ fan eternal optimism in all of us. In 2016, these fans showed us that optimism is not always misplaced. Fry is chair of the Cardiology Division at St. Vincent Health in Indianapolis, IN; chair of the Cardiovascular Service Lines for St. Vincent Health and Ascension Health; and the immediatepast ACC governor of Indiana. Health Policy Briefs CMS Releases Final Rule Detailing Bundled Payment Models for Cardiac Services The Centers for Medicare and Medicaid Services (CMS) in December released the final rule for Advancing Care Coordination Through Episode Payment Models; the Cardiac Rehabilitation Incentive Payment Model; and changes to the Comprehensive Care for Joint Replacement Model. The final regulation introduces a new cardiac rehabilitation model and a pathway that helps physicians who are heavily involved in bundled payment models to qualify for incentives as part of the Advanced Alternative Payment Model (APM) track under MACRA, beginning in performance year 2019. The final rule also creates new mandatory EPMs for the Acute Myocardial Infarction Model and the Coronary Artery Bypass Graft (CABG) Model. “As we move from volume-based care to value-based care, this new path for cardiologists to participate in Advanced APMs under MACRA’s Quality Payment Program (QPP) is a challenging step,” said ACC President Richard A. Chazal, MD, FACC. “It is our sincere hope that the end result will be opportunities for coordinated care and improvement in quality, while also decreasing costs for patients with heart attack or who undergo bypass surgery.” ACC Submits Comments on MACRA Final Rule The ACC submitted formal comments in response to the final MACRA rule released in November. In the comment letter to Acting CMS Administrator Andrew M. Slavitt, the College notes its support for the “depth of changes” included in the final rule as a result of public comments. However, the letter cautions that CMS “still has a heavy lift ahead in ensuring that the QPP is implemented in a way that truly supports improved patient outcomes without distracting clinicians from their priority of treating patients.” The letter highlights several key areas where further improvements are needed in order to achieve this goal, as well as encourages continued clarification and education on how best to implement 2017 QPP policies into practice. Moving forward, the ACC notes that “the continued refinement of the QPP will require ongoing dialogue between CMS and the clinicians, patients, vendors and other stakeholders affected by this program,” particularly as unforeseen issues arise. Learn more about MACRA and QPP implementation in ACC’s online MACRA hub ACC.org/MACRA. State Advocacy: What’s Ahead For 2017 What issues will state legislatures be tackling in 2017? Cardiology asked ACC’s Advocacy Team for their thoughts on the priority grassroots issues in the New Year. 2017 Public Health and Prevention Objectives: • Tobacco Control: Enacting legislation to raise the purchase age for tobacco products to 21, enacting smoke-free laws, raising cigarette taxes and increasing funding for smoking cessation are expected to be key issues in many states across the country. • CPR: Thirty-four states and the District of Columbia require instruction in cardiopulmonary resuscitation as a high school graduation requirement. Adding additional states and local jurisdictions is a high priority. • Physical Education: Required physical education in grades K – 12 and required recess in grades K – 6 are important tactics in the ongoing battle against childhood obesity. Two-thirds of states have no such requirements. The ACC will work with its State Chapters to encourage the increased implementation of required physical education and recess. • Sudden Cardiac Arrest: The ACC has developed resource materials for legislators and advocates outlining policies to prevent sudden cardiac arrest in scholastic athletes through training, education and on-site resources. State Chapters are encouraged to support legislation based on ACC principles. • Pulse Oximetry Screening: Most states have laws requiring lifesaving pulse oximetry screenings for newborn infants. Going forward, the College will work to strengthen these laws in states where they exist, while also working to implement requirements in states without existing legislation. 2017 Practice Management Objectives: • Medical Malpractice: An ongoing battle each session, the ACC will continue to oppose proposals seeking to repeal the current medical malpractice state litigation system and replace it with a workers’ compensation model, creating regulatory “expert panels” with authority to determine the validity of claims and patient compensation. • Emergency Care and STEMI: Determining how to best to leverage technology, data and trained personnel to improve door-to-balloon times and outcomes, while also opposing regulations whenever they become burdensome or duplicative, are priorities for the ACC and its State Chapters. • Access to Services and Prescriptions: The ACC will continue working with medical societies and patient advocacy groups to preserve provider autonomy and support patient-centered care by reforming prior authorization policies and opposing burdensome, costly steptherapy proposals. Get Involved The ACC provides resources and opportunities allowing members to communicate directly with local legislators and government officials and coordinate their advocacy efforts with local stakeholders. Learn more about getting involved with state advocacy efforts at ACC.org/Advocacy. Sponsored by Novartis Canakinumab: What Happens Next? Research from previous groups has established that inflammation is an important component of atherosclerosis.1-3 Therapeutic interventions targeting inflammation in atherosclerosis specifically for the reduction of cardiovascular risk, however, have not been studied. Interleukins (IL) , specifically, perform important mediating functions in inflammation. Previous animal research4 has suggested that IL-1ß is associated with a proinflammatory response, and has been shown to be inhibited by the presence of endogenous IL-1 receptor antagonists5, making it a natural target for proposed IL-1ß for inhibition therapies. To this end, results from a recent imaging study published in the Journal of the American College of Cardiology shed some light on whether IL-1ß inhibition with canakinumab had an effect on arterial structure and function. They also left researchers with some additional questions. Purpose and Design The study authors designed the randomized, placebo-controlled phase 2 study for the purpose of examining the effects of IL-1ß inhibition with canakinumab on vascular structure (using MRI-derived measures), diabetes control, and systemic inflammation. The sample included patients with atherosclerotic vascular disease and either impaired glucose tolerance or type 2 diabetes. The primary efficacy endpoints were the effects of canakinumab on aortic distensibility and total plaque burden within the aorta and the carotid arteries. Tolerability and the safety of the drug in the selected patient population were chosen as another important objective. In addition to the primary study objectives, the researchers also identified secondary study objectives, including measuring the effects of canakinumab on pulse wave velocity, hs- CRP levels, HbA1C levels, homeostasis model assessment -insulin resistance (HOMA-IR), and peak blood glucose level 2h following an oral glucose challenge. The researchers screened 450 patients for inclusion in the study, and ended up including 189 patients who were randomized to either canakinumab 150 mg monthly (n = 95) or placebo (n = 94) for a duration of 12 months. Integrated vascular MRI was used to assess patient status at baseline, 3 months, and 12 months. Mixed Results Using vessel wall area as a biomarker of atherosclerotic plaque burden, the researchers reported no statistically significant difference at baseline in mean carotid wall area between the canakinumab group and placebo group (27.7 ± 9. 79 mm2 vs. 27.1 ± 9.6 mm2; p = ns; see FIGURE for full measurements). The mean change in carotid artery wall area at 12 months was -3.37 mm2 in the canakinumab group vs. placebo (p = 0.06), suggesting a trend toward reduction in the progression of carotid plaque burden. There was no statistically significant difference in wall area between canakinumab treatment and placebo at any of the 3 aortic sites at either 3 or 12 months. There were also no statistically significant differences between the two study groups for the change in aortic distensibility, and no changes in systolic or diastolic blood pressure. Canakinumab did have an effect on hs-CRP levels, showing a reduction at 3 months vs. placebo (p < 0.0001) and at 12 months (p = 0.0002). In addition, IL-6 was reduced at 3 months (p < 0.0001). The researchers also reported that in the patient population with type 2 diabetes and “near universal statin use,” canakinumab had no adverse effect on plasma LDL or HDL levels vs. placebo at 3 and 12 months. There were no significant differences in major adverse cardiac events between the two study groups. Looking Toward the Next Phase Members of the research team noted that there were several points to take from the study results. Despite not meeting the primary endpoint, some of the other data were of interest. “If I had a take-home message, it would be that this drug works as an anti-inflammatory,” lead investigator Robin Choudhury, MD, PhD, of the University of Oxford, United Kingdom, said in an interview. “The hypothesis is still very much open to testing, as the trial didn’t meet its primary endpoint. If anything, it leaves us with more questions and more urgency to learn the results of the phase 3 study.” Co-author Jean-Claude Tardif, MD, of the University of Montreal in Quebec, Canada, agreed, adding that the drug being welltolerated was an additional point worth noting, as is the importance of the completion of the phase 3 study evaluating canakinumab (CANTOS- the Canakinumab Anti-inflammatory Thrombosis Outcomes Study). “The large phase 3 trial will provide a much more definitive answer to the clinical importance or relevance of what we’ve seen in the [current] imaging study,” Dr. Tardif said in an interview. “This is very important, because we’ve been talking about vascular inflammation for over a decade, and we’re close to seeing the first real impact on clinical outcomes of reducing inflammation in patients with diabetes or atherosclerosis. That answer will be scientifically and medically important.” Zahi Fayad, PhD, co-lead investigator on the study, said that the reported decrease in inflammation was “reassuring,” but also that questions remained. “We are left wondering what is going on with inflammation within the vessel wall; it is in one sense a positive study, but at the same time opens up another question related to the endpoint,” he said in an interview. “I do wish the endpoint had included measurement of the inflammation within the wall.” Dr. Fayad went on, emphasizing the need for future researchers to carefully consider their research goal, and to take extra care to choose the most appropriate plaque to measure. He also said the study researchers did not segregate the types of plaque they were looking at, and that future efforts should make sure to carefully consider patient selection based on plaque type. “We wonder sometimes if we should select lesions with certain characteristics, such as a lipidrich plaque, that can be identified,” he said. “Then, [we should] only enroll these types of patients.” Dr. Tardif put the results in the larger context of inflammation, adding: “We’ve been taught that inflammation is probably relevant in vascular disease, and now we are at this very exciting stage where we are going to see whether altering the inflammatory process in the vasculature will or will not have clinical impact on the lives of our patients.” REFERENCE Choudhury R, Birks J, Mani V, et al. J Am Coll Cardiol. 2016;68:1769-80. Http://content.onlinejacc.org/article.aspx?articleID=2565915 CITATIONS Libby P. Inflammation in atherosclerosis. Nature. 2002;420:868–74. Libby P, Ridker PM, Maseri A. Circulation. 2002;105:1135–43. Ross R. N Engl J Med. 1999;340:115–26. Kirri H, Niwa T, Yamada Y, et al. Atheroscler Thromb Vasc Biol. 2003;23:656-60. Isoda K, Sawada S, Ishigami N, et al. Atheroscler Throm Vasc Biol. 2004;24:1068-73. DISCLOSURE Dr. Choudhury was a Wellcome Trust Senior Fellow (Grant No. 088291/Z/09/Z), and has received honoraria/consulting fees from Amgen, Astra Zeneca, Boehringer Ingelheim, Isis Pharmaceuticals, GlaxoSmithKline, Merck, Roche, and Sanofi. Dr. Tardif has received research support from Novartis, Astra- Zeneca, Merck, Eli Lilly, Sanofi, DalCor, and Pharmascience. He has also received honoraria from Servier, Thrasos, and DalCor, and has equity interest in DalCor. Dr. Fayad has received research support from Novartis.
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