KevinMD had a great guest post recently by Mary Pat Whaley on the time associated with a patient visit. I think the title sums up the blog well: “Your 10-Minute Office Visit Needs 8 People and 45 Minutes of Work.”

As Whaley notes, even the shortest of office visits have a lot of work behind-the-scenes that needs to be done; seeing the patient is just a small part of the overall visit.  And, I would submit that far more than 8 people and much more than 45 minutes is required.   Health care is a regulation- and administration-heavy field, and this requires time to make sure the regulatory and administrative rules are followed. For example, HIPAA requires privacy forms to be filled out prior to the patient being seen. Verifying someone’s insurance information is time-intensive. Not to mention ensuring that we charge the patient the right co-pay based on their insurer and insurance plan. On top of that, pay-for-performance programs require time- and technology-intensive data collection during and after the visit. All of this, and more, makes up one “10-minute office visit.”

Whaley concludes: “The practice, the patients and the overseers of health care want each visit to be non-rationed, safe, high-quality, error-free, holistic, pleasant, clean, accurate, efficient and reimbursable.  It’s what we all want.  And it ain’t cheap.”

I have to agree with her. The complexity of the American health care system is incredible. And, the layers of complexity account for much of the cost. Our system has been built by accretion.  We “reform” the system by adding on layers of regulation, of bureaucracy, of administration.  As you look behind the eight people figured in this visit, the cost if not the time includes coders, compliance workers, claims specialists, re-claim specialists, computer network and now electronic health record experts,  lawyers, front office personnel, and even standard maintenance personnel for the  building.

As the regulation and administrative burdens add on, the cost of practicing gets greater and it is harder to cover these expenses with income.  Add to that more and more cuts to cardiology, and it’s no wonder that a large number of private cardiology practices are integrating with hospitals. Last year, the ACC reported the results of a survey of ACC members that found nearly 40 percent of private group practices were currently integrating with hospitals or merging with other practices. An additional 13 percent of all cardiovascular practices were considering hospital integration or a merger in the next three years to help stem the financial burden.

These are uncertain times for cardiology and for the House of Medicine in general.  To be clear, the ACC supports the triple aim of better health, better health care, and at less cost. But to get there, we will have to deal with the repercussions of massive changes, and may I say probably the accretion of more layers, to our health care system. In my opinion, “dealing” with the repercussions will not be enough – we need to shape the discussions if we want to be pleased with the health care system structure of the future.  And, maybe we can even help peal away some of the layers.

The ESC Congress for the first time is having two sessions dedicated to clinical registries in order to highlight the growing number of innovative registries, the data they collect and the conclusions that can be drawn from this data. The sessions focus on “Risk and Treatment Reality” and “Interventions and Devices” and showcase registries from France, Italy and more.

The prominent treatment of the registry data trials at ESC Congress 2011 is a testament to their growing importance. Registry research is unique because it uses real-world data. The patients included in the registry are not chosen because they have limited comorbidities or fit a certain profile, like in clinical trials, but are included simply because they are a patient at a participating hospital. What this means is that we can see what the effects of certain treatments are on patients who may never qualify for a clinical trial. The results are a better understanding of adverse outcomes and better treatment protocols. The ACC frequently requests for FDA to require new drug and device manufacturers to conduct post-market approval studies through registries to ensure that the new drug/device doesn’t have any adverse events not caught in the clinical trials.

Of course, that’s not to say that registries aren’t without limitations. Currently, it’s challenging to connect care between the outpatient and inpatient settings because the U.S. will not implement a unique patient identifier system that could connect a patient’s progress in the hospital to the ambulatory setting and, in some cases, back to the hospital. We’ll need to find a way to work around this. With the growing emphasis on reducing readmissions, hospitals will need to have a better understanding of why and which types of patients are most frequently readmitted. Registries should be able to help fill this gap.

ACC’s registries suite, NCDR (National Cardiovascular Data Registry), has experienced a landmark year in terms of the science researchers have produced. The following studies have been some of the most interesting:

1. Non–Evidence-Based ICD Implantations in the United States (JAMA, 305;1). Researchers found that ICD implantations were not in accordance with practice guidelines in 20+% of patients, most commonly because of newly diagnosed heart failure or an MI within 40 days.
   
   
2. Patterns and Intensity of Medical Therapy in Patients Undergoing PCI (JAMA, 305;18). The authors conclude that optimal medical therapy is underutilized in patients with stable CAD.
   
   
3. Association of Door-In to Door-Out Time with Reperfusion Delays and Outcomes Among Patients for Primary PCI (JAMA, 305;24). Study showing improvement is needed in the treatment of heart attack patients who require transfer to another hospital for primary PCI).
   
   
4. Appropriateness of Percutaneous Coronary Intervention (JAMA, 306;1): This study concluded that although the majority of patients are appropriately selected for PCI procedures, there are opportunities for improvement, especially in the non-emergency setting.
   
   
5. Hospital Variability in the Rate of Finding Obstructive Coronary Artery Disease at Elective, Diagnostic Coronary Angiography (JACC, 58;8). Former ACC Prez Pam Douglas, MACC, et al., find that hospitals vary greatly when it comes to the rate at which obstructive CAD is found in patients without known heart disease undergoing elective diagnostic coronary angiography or catheterization.

These are just five of the hundreds of studies using NCDR data that have been published over the registries’ 14-year history. We may not always like what the studies find, but it’s the measurement that pushes cardiology as a profession to move forward and to find ways to more consistently implement best practices and guidelines. By measuring patient care in an appropriate and actionable way, registries bring to light the invaluable improvements being made by physicians and care teams.

I commend ESC for bringing registry data to the forefront of their meeting. I think we’ll see more and more about registry data in the future, as it addresses some of the gaps left by clinical trial data.

The prestigious Institute of Medicine (IOM) earlier this month opined concerned that most medical devices are cleared for sale without sufficient evidence that they are safe and effective -- even though we tend to delay approvals of devices far longer than the EU, Canada and most of the developed world. IOM’s assessment should give everyone pause -- particularly because they declared the current regulatory approach (related to the FDA 510K approval process) to be so messed up that we should scrap it and start over. FDA reacted immediately that they disagreed, stating they would instead work to fix the problems acknowledged in the 510K regulatory system.

The IOM committee found no major new horror stories related to existing devices on the market, but worried that FDA and the public have no good way to determine where risk may exist because there is virtually no good clinical data to rely on. Hello. The NCDR has the clinical data they seek; and if we could get the feds to offer incentives to help us diffuse the PINNACLE Registry across more outpatient practices, we could track post-approval performance and look for even low-signal adverse events incredibly effectively!

The IOM committee commented specifically on what they termed "highest-risk" CV devices, such as implantable defibrillators and replacement heart valves. They noted that clinical trials with relatively few enrolled patients are used to demonstrate safety and effectiveness of such devices, deeming that they afford only a “moderate risk,” based on having the manufacturer show that they are “substantially equivalent” to devices previously cleared. The added concern is that those devices in turn may have been cleared because they were “substantially equivalent” to earlier devices that may no longer be in use -- a ‘house of cards’ process.

IOM deserves credit for spotlighting the issues. But, not only the FDA objected to IOM’s recommendations: the device industry, already frustrated with the cumbersomeness of the 35-year old 510K process, are yet even more worried about and opposed to completely scrapping the process. They want to see it streamlined instead. What we need to do is show FDA, IOM and industry what the broad use of registries could do to carefully track ALL patients who are device recipients. That’s what needs to happen! Upcoming FDA hearings on the IOM recommendations and the future of the 510K process will give us an opportunity to promote this potential of using our registries to provide more rigorous and effective surveillance of CV devices after they are on the market.

On Monday I had the opportunity to speak on CBS Radio to respond to a Consumer Reports article on “The Business of Healing Hearts.” The article provides a critical look at how heart disease is treated across the country. The basic points of the article are as follows:

• People often get the wrong tests
• Angioplasty is overused
• Consumers don’t have enough information on cardiologists
• Heart disease is often misunderstood

The article discusses how financial incentives, such as direct-to-consumer advertising or fee-or-service payments, drive patients to seek care that is not necessary and drive physicians to subject patients to “fancy tests” and aggressive treatment that aren’t necessarily the best care. The report notes that PCI procedures are often overused in the nonemergency setting and that patients cannot find useful information about interventional cardiologists.

In general, the report underscores why reform of our current payment system is so needed. The current focus on volume and episodic care without regard to improved quality, better patient outcomes or patient satisfaction limits communication and creates hurdles to achieving the triple aim of better health care quality, better health and lower costs. It’s why the ACC is proactively advocating for a new payment system (or systems) that rewards improved coordination of care, team-based care delivery, appropriate use of tests and procedures and improved medication adherence to treatment therapies.

In my interview with CBS radio, I also noted the growing importance of “appropriate use criteria” (AUC) in helping allay some of the fears noted in the report. AUC are developed in partnership with key specialty societies to help define “when to do” and “how often to do” a given procedure in the context of scientific evidence, the health care environment, the patient’s profile and a physician’s judgment. Appropriate Use Criteria for Coronary Revascularization were developed in 2009 by the ACC using a combination of clinical science, knowledge and expert opinion to help understand when PCI is appropriate, not appropriate or uncertain. However, it can be challenging to implement AUC into practice. The ACC is looking at new ways to harness technology that can place the documents and other clinical documents like guidelines at the point of care.

Registries are also a key component of high-quality, cardiovascular care. The ACC strongly believes in the power of registries to improve the patient care experience. The Consumer Reports article notes that patients should ask their hospital if it participates in the NCDR because participation in the registry can help the hospital to monitor their performance and adopt quality improvement initiatives to optimize the care they deliver. Fred Masoudi, MD, FACC, is quoted in the article and says that NCDR is working to make NCDR metrics more accessible.

The majority of CV professionals are doing the right thing, but the ACC recognizes as with any industry, there are outliers and that there is always room for improvement. The ACC is proactively working to identify innovative ways – along with all the tools we already use, like NCDR registries, clinical documents and quality programs – to ensure high quality, cost-effective care for every patient.

I look forward to hearing your thoughts in the comments section below.

A new study based on NCDR CathPCI Registry data has found that a vast majority of percutaneous coronary intervention (PCI) procedures performed in acute settings are appropriate; however, in the approximately 30% of non-acute settings, there was more variability in the grading according to ACC’s Coronary Revascularization Appropriate Use Criteria (AUC).  The study, published in JAMA, examined records from 1,091 U.S. hospitals captured between July 1, 2009, and Sept. 30, 2010, and included 500,154 cases. It found that 98.6% of PCIs performed during acute episodes of care were classified as appropriate, 0.3% were considered uncertain and only 1.1% were considered inappropriate.   

In the 30% of cases performed in more elective settings, 11.6% were classified as inappropriate. There was substantial variation noted across hospitals.  The reason for the variability may relate to multiple factors, and include patient or family expectations, un-quantitated patient characteristics, or other factors such as the practice setting. 

Background
In May, the CathPCI Registry began issuing reports to participating hospitals that offered them the ability to compare their performance against peer hospitals using ACC’s Coronary Revascularization AUC. These AUC are intended to identify care and variability in procedural performance.   Criteria for PCI have been developed by a broad group of surgeons, interventional cardiologists and general cardiologists.  Three categories (appropriate, uncertain, inappropriate) were tabulated for multiple short clinical and angiographic scenarios.  PCI was categorized as appropriate or uncertain if there was some debate of its merits, or inappropriate if there was general consensus that PCI was not merited in the specific scenario.   These criteria were then applied to patients undergoing PCI entered into the NCDR CathPCI Registry. 

The ACC believes that providing facilities with their rate of appropriate use of PCI procedures will encourage assessment and evaluation of their practices.  Identifying variability in performance compared with other hospitals can be used to develop quality improvement initiatives to ensure more optimal use of PCI and reduce either potential overuse or underuse depending on the specific setting. The Chan, et al., study represents an application of the CathPCI Registry AUC reports and highlights the value that NCDR registries can play in identifying practice patterns for individual hospitals and practices, identifying variability in performance and studying the reasons for this variability. 

Caveat
The results of the study should be interpreted knowing that AUC are suggested approaches to care. The AUC criteria represent the knowledge and experience base present at the time when the criteria are written, but there may be times when what is best for the individual patient is at variance with AUC or guidance documents. It must be remembered that AUC should not take the place of detailed discussion of the risk benefit ratio of potential procedures with the patient and family in concert with the physician providing care for that specific patient.  That interaction is crucial to patient-centered team-based care. Clinical judgment and full patient understanding should always guide care. 

More Resources
For more information on the study, click here. You can also learn more about the College’s ongoing efforts related to appropriate use of PCI and other therapies and procedures in the “Appropriate Use” issue center on CardioSource. The Wall Street Journal had a fairly balanced story on the article this well as well if you want additional perspective.

 

I was excited to be asked to attend to an invitation-only CMS meeting on Thursday of 25 leaders and CEOs of a few health constituencies with federal officials to discuss the potential of using registries and clinical data to improve care and lower costs (at long last). The gathering was co-chaired by CMS Administrator Don Berwick and Harvard Business School economist and health policy strategist Michael Porter. Berwick asked me to make some opening statements, and I presented the ACC experience and vision for NCDR, PINNACLE, and registries in general. What an opportunity! The few people invited were those he felt had influenced him along the way on the importance of using registries to achieve the triple aim (improving health care, improving health, lowering costs). It was a very good conversation.

Michael Porter discussed his research on registries in other parts of the world, and what they are accomplishing when done right. He noted that wherever he looks, that registries -- even voluntary ones -- improve outcomes, and this leads to improved clinical care models and lower costs. His data from Sweden is compelling. Interesting that this week’s JAMA highlights Sweden’s registry-produced data demonstrating the clear association between adoption of evidence-based guidelines and improved survival for ST-elevation myocardial infarction. We need more research of this kind here.  The guidelines are valuable -- along with clinical judgment.

Berwick may have been steering this conversation toward opening the doors to more federal support for registries and clinical data. The Office of the National Coordinator for Health IT is definitely on board, too. Farzad Mostashari (its head) is a big supporter of ACC and STS as well.

So what was the bottom line here?  Progress was made; but believe me there’s more convincing to do. More federal officials and agencies apparently see the value and necessity here of getting clinical data, adherence to guidelines (or routine comments as to why not), and routine feedback on performance to doctors and hospitals. The final agreement was to have follow-up calls, and to explore how to fund some diffusion of registries through the CMMI (CMS Innovation Center) and AHRQ.

We at ACC and STS need to assure that the follow through on our part will occur. We've been lobbying for registry awareness for far too long. 

The Centers for Medicare & Medicaid Services (CMS) last week issued a report that highlights significant trends in the growth of two “pay-for-reporting" programs: the ePrescribing Incentive Program and Physician Quality Reporting System (PQRS...formerly known as the Physician Quality Reporting Initiative or PQRI). According to the report, 2009 Physician Quality Reporting System and ePrescribing Experience Report, 119,804 physicians/eligible professionals in 12,647 practices received incentive payments under PQRS totaling more than $234 million—well above the $36 million paid in 2007, the first year of the program. Under the ePrescribing Program, CMS paid $148 million to 48,354 physicians/eligible professionals in 2009. Results show that participation in PQRS has grown at about 50 percent every year, on average, since the program began.

On average, 2009 bonus payments for satisfactory reporters in PQRS were $1,956 per eligible professional, but $18,525 per practice that participated. Eligible professionals received even more from the ePrescribing Program in 2009: the average bonus payment was just over $3,000 per eligible professional and $14,501 per practice.

The report also shows health care professionals report complying more often with evidence-based care practices. Based on reported data on the 55 measures that have been a part of the PQRI/PQRS program since it began in 2007, providers have improved the frequency for which they deliver recommended care by about 3.1 percent on average. Similarly, of the 99 measures that were part of the System in 2008 and 2009, performance improved at about 10.6 percent on average. In some cases, gains have been even more dramatic. More about the report is available on the CMS website.

The incentives are still trivially small to really move the system. At least our PINNACLE Registry users got fully reimbursed with no hassles through the PQRS program. For 2009, 172 providers from 14 practices used the PINNACLE Registry to report --100% successfully--with an average payment of $8,352 per provider. But the CMS incentives need to be made much more significant if we want these programs to work and to significantly improve quality systematically.

Last night I officially turned over the gavel to David Holmes, MD, FACC, marking the end of my presidency of the ACC. This past year as president has been rewarding, but it’s also been incredibly challenging. When I first took over from Alfred Bove, MD, PhD, MACC, I identified the theme of my presidency as “professionalism,” knowing that the year would bring many changes that would require others in the health care arena to view us as true professionals, not just a guild.

Reflecting on the past year, I feel that we’ve accomplished a lot in proving ourselves as such. We are viewed by many as a forward-thinking, professional society, and as a trusted resource when it comes to cardiovascular science and education expertise. We are also increasingly the go-to organization for issues involving quality assessment, appropriateness of cardiovascular care, and new care delivery and payment models. Our efforts to date have been consistently recognized by the White House, Congress, Medicare, National Institutes of Health, the Agency for Healthcare Research and Quality, FDA, patient advocacy groups and our partners in the medical community.

This is not to say the year has been without struggle. Interventional cardiology has been accused on multiple occasions of overuse of coronary stenting procedures. Electrophysiologists received similar criticism when a JAMA article, based on NCDR ICD Registry data, reported the presence of inappropriate implantation of ICDs for primary prevention of sudden cardiac death in Medicare beneficiaries. Health care reform and other regulatory changes have placed cardiology in an uncertain position – where will the profession be 5, 10, 15 years from now? Will there be “private practice” as we know it today?

The ACC has worked to overcome these challenges by taking a leadership role, rising to the occasion of “knights of cardiology,” and proving to the world that we will not stand by and be simply knaves or pawns. We are quality in action.

Under Holmes’ leadership, we will continue this tradition of professionalism, with Holmes bringing additional focus on education and science. Whether it’s through education, science, quality programming, professionalism or advocacy, we are making a collective difference and saving the lives of countless patients in the process.

Thank you for the past year of my presidency, and for the opportunity to hear your concerns and questions through the ACC in Touch Blog. Although I’ll no longer be an author here, I hope to have frequent “guest blogs” where I can continue to hear your feedback. Thank you for all that you do.

*** Image from Flickr (walknboston). ***  

By W. Douglas Weaver, MD, MACC, chair of the CathPCI Registry Steering Committee and former ACC president

*****

Beginning in May, the NCDR CathPCI Registry reports will provide participating hospitals the ability to compare their performance against peer hospitals using ACC’s Coronary Revascularization Appropriate Use Criteria (AUC). These AUC are based on the Coronary Revascularization Guideline, and are intended to show whether PCI was appropriate, inappropriate or uncertain for each patient entered into the registry database.

This is important for a number of reasons. As can hardly be missed, the overuse of stenting has been suggested in several places and been the subject of state investigations both in Maryland and most recently, in Pennsylvania. Inclusion of AUC metrics in the CathPCI Registry is one step being taken by the ACC to enable well-intentioned cardiovascular professionals to determine whether their case mix of appropriate use is similar to other sites in the registry and enables them to benchmark performance. The data will be reported at the hospital level, but will also include a listing of the inappropriate cases, which will allow the hospital and interventionalists to review any such cases.

There are some important caveats. The metrics are currently considered “test metrics,” meaning that we’ll be modifying them if we determine from feedback that some of the data was either inaccurate or incomplete. To do this, we’ll be leaning heavily on CathPCI participants to make sure that they are vigilant in providing the highest quality of data possible. At this time, we believe that the metrics are not valid to be used in health plan payment programs or for public reporting purposes. The ACC will be using the experience gained during the metric testing phase to refine and enhance the value of AUC to aid professionals in improving quality of care and enhancing patient outcomes.

The ultimate goal is two-fold: offer a greater value to participating hospitals and physicians in the CathPCI Registry and to improve the quality of care provided to patients with cardiovascular disease. More information is available on the NCDR website.

If you’re interested in learning more of the topic, I encourage you to attend a session with Paul Chan, MD, FACC: “Appropriateness of PCI in the U.S.: Insights from the NCDR CathPCI Registry,” from 8-9:30 a.m. tomorrow in Room 238.

Yesterday we held a great spotlight session on health IT at ACC.11 & i2 Summit. The morning session featured Mike Mirro, MD, FACC, Health IT Committee co-chair, of Fort Wayne Cardiology, Jeff Westcott, MD, FACC, of Seattle Cardiology, and Lee Goldberg, MD, FACC, of the University of Pennsylvania, discussing their experiences implementing an electronic health record (EHR) in various practice settings. The session included a Q&A with the group, along with John Windle, MD, FACC, and Jay Alexander, MD, FACC, both of whom were panelists at last year’s Health IT Spotlight Session.

In the afternoon, John Harold, MD, MACC, Ralph Brindis, MD, MPH, FACC, and I attended the 2^nd part of the Health IT Spotlight Session, which discussed the Medicare EHR Incentive Program and what providers can do to qualify. Farzad Mostashari, MD, ScM, Deputy National Coordinator for Programs and Policy at the Office of the National Coordinator, gave the keynote address. Mostashari discussed the program, which has $17.2 billion in incentives to assist providers in adopting health IT. From 2011-2015, physicians who demonstrate “meaningful use (MU)” of EHR technology and performance will be eligible for positive payment incentives. Mostashari discussed at length what exactly “meaningful use” is and how providers can demonstrate that they’re doing it. (You can view the specifics of MU on CardioSource.) He also highlighted ACC’s opportunities to lead in leveraging MU to promote the triple aim, and encouraged us to act. Carpe diem.

Following Mostashari’s keynote, ACC Health IT Committee Co-Chair James Tcheng, MD, FACC, discussed which providers and hospitals are eligible and under which program (Medicare or Medicaid) they are able to participate. Understanding if you’re eligible to participate in the Medicaid program is critical, because there are greater financial incentives available under that program than the Medicare program.

Finally, Floyd Eisenberg, MD, MPH, senior vice president for health IT at the National Quality Forum, concluded the session with a discussion of electronic quality reporting. Under the program, electronic data collection is required for quality measures, and his discussion made it clearer about how providers and hospitals can submit this data.

If you missed these great sessions, you can still learn more about health IT. At 11:15 today, there will be a Health IT Gadgets & Gizmos "Show & Tell" in the ACC Central Theater (Booth #1947).