A more multidisciplinary and team-based approach in research and clinical settings. More use of registries and EMRs. More trends showing healthier patients. And, above all others, more of a push to find value and cost savings in a changing reimbursement environment. Those are the take-home messages for the cardiovascular community from leaders in research, practice, government and business as they share their perspectives on 2012's challenges and opportunities.
Trials and tribulation
The prospects of cardiovascular research in 2012 lend to both excitement and concern, according to Anthony N. DeMaria, MD, editor-in-chief of the Journal of the American College of Cardiology, and director of the cardiology center at the University of California, San Diego School of Medicine. Closer collaborations among cardiologists and other specialties, for instance, may be opening the door for insightful studies; cardiovascular registries now are in place to inform both research and practice; and follow-up studies from recent landmark randomized controlled clinical trials are poised to answer critical questions about cost-effectiveness.
Simultaneously, concerns about the shift of innovative research from the U.S. to overseas possibly may grow from chatter to a crescendo in 2012.
"There is going to be a continuing and perhaps increasing focus on the difference in trial results between various geographic locations," DeMaria predicts. "Are the results that you obtain in one area of the world with one set of patients with their own genetic and socioeconomic conditions applicable to patients in another part of the world with slightly different genetic and socioeconomic conditions?"
In an analysis of National Heart, Lung and Blood Institute (NHLBI)-supported cardiovascular randomized controlled clinical trials, Kim et al found that 19 of the 24 studies included international participants (J Am Coll Cardiol 2011;58:671-676). International participants made up nearly half the enrollment in the 11 coronary artery disease trials in the analysis.
"Why is it that devices, therapies and procedures that initially were invented in the U.S. go outside the U.S. for their clinical evaluations?" DeMaria asks. He is not alone in his questioning. The NHLBI launched its Clinical Research United in Successful Enrollment initiative in 2010 followed by a workshop to examine barriers that have led to the outsourcing of clinical trials.
Workshop attendees identified the high costs of recruiting and retaining study participants as one deterrent; in October, the co-chair of the workshop published recommended strategies to help regain prominence in the U.S., including budgeting tools and reimbursement agreements for covering the costs of investigational items (JAMA 2011;300:1798-1799).
In the meantime, DeMaria anticipates that large randomized trials that compared novel anticoagulants to warfarin may release cost-effectiveness data as soon as 2012. Those trials include ARISTOTLE, which found that the Xa inhibitor apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) reduced the risk of stroke or systemic embolism by 21 percent, major bleeding by 31 percent and death by 11 percent (N Engl J Med 2011;365:981-92). The ARISTOTLE paper came on the heels of the ROCKET-AF trial, which showed promising results for the factor Xa inhibitor rivaroxaban (Xarelto, Bayer Healthcare). But at what price? "That is critically important, particularly because warfarin is a relatively inexpensive drug compared with these other agents," DeMaria says.
DeMaria sees registries such as the American College of Cardiology's (ACC) PINNACLE (Practice Innovation and Clinical Excellence) playing a key role in research in 2012. The cardiovascular outpatient database includes more than two million records of U.S. patients and includes a network of thousands of cardiology practices. "There is a lot of information that will come from registries that will help inform practice, but more than that, it will point out issues that need to be improved," he says.
Registries like PINNACLE will be especially critical for identifying cost-saving opportunities, as anticipated federal reimbursement cuts nip into expenditures. "It seems to be clear that we won't be able to keep spending, so the question is, what are we doing that isn't of great value? These registries are going to point to the answer," DeMaria says.
Expect more multidisciplinary partnering in research institutions and hospitals in 2012, say DeMaria and Steven E. Nissen, MD, chair of cardiovascular medicine at Cleveland Clinic. DeMaria points to the growing numbers of cardiologists collaborating with specialists such as nephrologists to study cardio-renal syndromes and diseases, such as diabetes that affect both the heart and kidneys.
The cardiovascular clinical setting is becoming more collaborative and multidisciplinary, at least for complex procedures such as transcatheter aortic valve implementation (TAVI), which has been performed at the Cleveland Clinic's Heart and Vascular Institute in an investigational phase on patients with severe aortic stenosis who are not candidates for surgery in the PARTNER trial. The FDA approved the Sapien transcatheter heart valve device (Edwards Lifesciences) on Nov. 2, allowing practices to offer the procedure to patients.
"You have five, six or seven physicians involved in a single case," Nissen says. "This is the sort of procedure in which you need a multidisciplinary team."
The Society of Thoracic Surgeons (STS) and ACC issued recommendations in July that called for a hybrid operating room and at least four specialists to be involved in any TAVI procedure: a primary cardiologist, an interventional cardiologist, a cardiology surgeon and an echocardiographer. The Heart and Vascular Institute, with more than 200 staff physicians, 110 fellows and residents and a large nursing staff, can provide the depth of expertise needed for TAVI, Nissen says. The clinic, which performed 55 TAVI procedures in 2010 and 84 as of late October, also has been ramping up in anticipation of approval.
The multidisciplinary team-based approach will make inroads in 2012 in treatments for other syndromes such as coronary artery disease, DeMaria says. Traditional competitors, cardiologists, surgeons and radiologists, are beginning to see advantages in combining the cardiologist's understanding of anatomy, for instance, with the radiologist's imaging expertise to provide better patient care.
Like DeMaria, Nissen anticipates the cardiology community will face a more difficult reimbursement climate in 2012. Under a proposal by the Medicare Payment Advisory Committee (MedPAC), specialists could face a 5.9 percent decline in Medicare reimbursements per year for three years for their services. "Any executive who is trying to balance the books in cardiovascular medicine is going to have to recognize that we're not going to get paid more for what we're doing," Nissen warns.
Nissen also forecasts a shift from some patients being treated in the hospital setting to less expensive outpatient settings, and a decrease in the frequency of procedures such as coronary interventions. He credits medical advancements that are helping people become or stay healthy as contributing to less need for interventions. And the numbers bear him out. In October, the Centers for Disease Control and Prevention (CDC) announced that the prevalence of coronary heart disease in the U.S. declined from 6.7 percent in 2006 to 6 percent in 2010, due in part to therapies for risk factors such as high cholesterol and high blood pressure.
Goals for Million Hearts Initiative
|Aspirin use for people at high risk||47%||65%|
|Blood pressure control||46%||65%|
|Effective treatment of high LDL cholesterol||33%||65%|
|Sodium intake (average)||3.5 g/day||20% reduction|
|Artificial trans-fat consumption (average)||1% of calories/day||50% reduction|
|The federally sponsored Million Hearts program is designed to prevent a million heart attacks and strokes over the next five years.|
In a massive effort to curb healthcare costs and improve outcomes, the CDC and the Centers for Medicare & Medicaid Services unveiled the Million Hearts initiative in September, a program designed to prevent a million heart attacks and strokes over the next five years. The cornerstone of the program is the application of clinical interventions that focus on four components, called ABCS: aspirin for high-risk patients; blood-pressure control; cholesterol management; and smoking cessation.
While Janet S. Wright, MD, executive director of the Million Hearts initiative, has high expectations for the program in 2012, she doesn't list making a significant dent on mortality rates among them. Instead, she sees 2012 as a year of building partnerships with cardiology and medical associations, other government agencies, industry and the cardiovascular professionals who are in direct contact with patients as an important step toward meeting the five-year goal. Those professionals will range from cardiologists and cardiovascular surgeons to nurses, pharmacologists, pharmacists and technicians.
"This is not new science or new evidence," says Wright, referring to the preventive interventions. "This is actually executing on the strategies that we know are effective for keeping people healthy and preventing disease. If we do those two things, our population will be healthier; the cardiovascular disease burden—the personal and the economic burden—will start to drop away.
"Will we see those results drop 12 months from now? No." But she added that they could see trends head in the right direction with this nationwide initiative.
Wright says that Million Hearts will build off existing partnerships and forge new ones to provide clinicians with the information and tools they need to treat and educate patients. Those tools might include clinical decision-making support such as prompts within an EMR.
ABCS-related indicators also are being embedded into meaningful use criteria and into quality-recognition programs such as the Physician Quality Reporting System, potentially giving providers financial incentives to follow these metrics.
Partners such as the ACC and the American Heart Association (AHA), with its Guideline Advantage and Get With the Guidelines programs, will fill dual needs in 2012, Wright says. The ACC and AHA programs take advantage of EMRs and heath IT to collect and analyze data on ABCS outcomes. For Million Hearts, which has no definitive nationwide database to gauge its progress, the platforms may give snapshots of cardiac-related patient subsets of U.S. population health. For participating cardiovascular clinicians, the ACC and AHA may provide feedback and a way to benchmark their success at meeting ABCS targets.
Equally important for 2012 and beyond, Wright says, is that the partnership-building phase of Million Hearts will serve as a model for future efforts to manage and prevent chronic diseases, particularly when those efforts unite previously siloed federal bodies. "Two things will come from this work," Wright predicts. "One is a methodology to tackle tough clinical issues and two is a greater awareness across agencies in the federal government to identify opportunities to work together and synergize in unique ways."
Pragmatic in the face of pain
William T. Carlson, Jr., Esq., a former hospital administrator and veteran lawyer with Maynard Cooper and Gale in Birmingham, Ala., specializes in cardiology practice integration deals. He sees a sea change in the perceptions of cardiovascular thought leaders, independent cardiovascular practices and hospitals as cardiologists and executives brace for potential Medicare cuts in 2012. He also sees EMRs impacting cardiovascular businesses in 2012, but not necessarily in a positive way.
EMRs that can't be easily linked may not be a deal breaker for cardiology practices and hospitals as they negotiate service-line or integration contracts, but they can complicate the process and add to costs, Carlson says. Vendors that may claim the best-in-class EMR option for hospitals may not have a comparable product for cardiology practices. These considerations may leave cardiologists with tough decisions if they want to align with a hospital or institution.
"One of the biggest problems we assess when putting together an integration deal is whether we are going to cancel out a cardiology group's EMR and essentially force them to start over and learn an entirely different way of entering data and interfacing with the record," Carlson says. "Or, are we going to try to build a user interface between the physician's existing record and the system the hospital uses?"
Either strategy has cost implications, whether it is replacing the existing EMR despite the time and money invested, or buying add-ons to patch the EMRs together.
Integration deals in 2012 may differ from negotiations of past years, Carlson says, because many of the larger and stronger practices interested in integrating with a hospital have already done so, often on their own terms. That may not be the case in 2012.
"The practices that are integrating today are more challenging, not only because the groups tend to be smaller, but they also tend to have fewer options," he says. "They have strategically placed themselves in a position where there are not multiple bidders for the group, and by definition that narrows their negotiating power. That, in turn, narrows the terms under which you can integrate."
Carlson counsels hospitals in these circumstances to fight the urge to "go cheap" and instead to consider the future relationship they want to build.
2012 is shaping up to be a year of pragmatism for cardiologists and administrators as they contemplate changes in reimbursement and compensation, Carlson says. He describes the current state as a productivity model with reimbursement tied to volume. But the shift toward bundled payments, whether it is based on an episode-of-care model or a capitation model, likely would affect how a group earns money and how the group then distributes earnings to individual physicians.
"Cardiologists and administrators must decide, 'What behavior do I want to reward and what behavior maximizes revenue?'" Carlson says. Such questions may led to changes in practice, for instance, rethinking the suitability of some procedures for the very elderly or training interventionalists to employ radial artery rather than femoral artery catheterization for PCI procedures. The radial approach has been shown to have a lower rate of vascular complications, require shorter hospital stays and potentially provide lower costs (Lancet 2011;377:1409-1420), (J Am Coll Cardiol Intv 2010;31011-1019).
Carlson credits groups such as the Medical Group Management Association, the STS and MedAxiom for helping cardiologists adjust their expectations as they enter this period of flux. That includes a realization that they need to focus less on revenue opportunities and more on cost savings.
"The cardiologists and healthcare providers, in general, believe that this is not a zero-sum game; we are at a decline-sum game in terms of revenue available to the healthcare industry," Carlson says. "The hospital CEOs are driving, and cardiologists are signing up for, this idea of cost reduction."
Given that scenario, 2012 likely will be a period of painful transition, he suggests. "The pain is the declining pool of money. But that does not mean there is not going to be some benefits that result."