On Monday I attended a plenary about managing patient expectations in the face of the current cost-savings-focused environment. As doctors, we sometimes find that patients want the most expensive care or the most tests as part of their treatment because they view it as the “best” care they can receive. However, this usually isn’t true. The best care is the care that’s been validated by science – and high quality science at that. This can be difficult to come by, even in the field of cardiology, which compared to other specialties, has some of the best research available.

Why does cardiology have some of the best, most comprehensive research? Because cardiology has registries, and we use them to collect data in real-life, which we then turn into the research that informs the clinical documents that guide everyday practice. The ACC has a suite of six registries (NCDR) that together pull research from nearly 2,000 hospitals and 180 practices (yes, one of those registries is an ambulatory registry – the PINNACLE Registry -- formerly called the IC3 Program).

At AHA, research from the NCDR is making quite an appearance. There’s a total of 14 abstracts from the NCDR out at AHA, which hopefully you had the opportunity to check out: five abstracts from the CathPCI Registry; four from the ICD Registry, one from the CARE Registry, two from ACTION®-GWTG™ and two from the IC³ Program (now the PINNACLE Registry).

Of particular excitement are the two abstracts from ACC’s IC³ Program/PINNACLE Registry. The first is an oral presentation by Paul S. Chan, M.D., M.P.H., on “A Report of the First 10,000+ Patients.” The study found nearly three in five enrolled patients had coronary artery disease (CAD) and all the outpatient performance measures (PMs) could reliably be assessed. Adherence to the CAD PMs was often suboptimal, suggesting substantial opportunity for improving the quality of outpatient care.

The second (a poster presentation by ACC staff members Kristi Mitchell, M.P.H., and Sunil Gupte, Ph.D.) is “Electronic Medical Record Adoption in Cardiology Practices: A 2009 Snapshot.” This study found EMR adoption within PINNACLE Registry (then the IC³ Program) is slightly greater than that reported in the literature and may be due to the greater number of large practices enrolled. The PINNACLE Registry provides a foundation to analyze EMR adoption and implementation rates in U.S. cardiology practices and to observe trends associated with reducing some of the financial barriers due to the recent provision of federal funding. As such, the PINNACLE Registry will be positioned to determine the impact of EMR usage on clinical quality and patient outcomes.

The large number of abstracts presented at the meeting is a testament to the rich evidence coming from these groundbreaking registries. We need to keep moving forward with our efforts so that ALL clinical decisions can be made on the basis of the strongest level of evidence.

UPDATED: 11/19 with video.

BIG news this morning from the ACC. After learning some lessons from our pilot program IC³, the ACC is launching the first-ever registry-based network for cardiology practices, called the PINNACLE Network. Its goal is to give practices the tools they need to be both innovative and high quality.  Learn more from the press release below or watch the CVN video.

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AMERICAN COLLEGE OF CARDIOLOGY LAUNCHES THE NATION’S FIRST
REGISTRY-BASED CARDIOVASCULAR PRACTICE NETWORK

Washington, DC – The American College of Cardiology today announced the launch of the PINNACLE Network, the first-ever registry-based cardiovascular network to link thousands of cardiology practices to each other and to the ACC’s National Cardiovascular Data Registry (NCDR), the preeminent cardiovascular data repository in the United States.

The PINNACLE Network™ immediately addresses the rapidly shifting business environment that private cardiovascular practices face with a wealth of practice management and financial management tools. The PINNACLE Network™ also builds a foundation for innovative, registry-based systems to reward practices for the high quality care that they provide.

“With the legislative and regulatory threats to traditional payment systems and the emergence of value-based payment programs, the ACC is in a unique position to develop and offer the PINNACLE Network™ with its suite of practice management tools to help practices not only survive but thrive,” said Alfred A. Bove, M.D., Ph.D., president of the ACC.

A comprehensive practice management system, the PINNACLE Network™ provides financial management tools to help practices thrive; workforce strategies to enable physicians to meet the increasing demand for cardiovascular care; guidance for the adoption of health information technology; and risk management education and strategies to lower the cost of liability premiums.

The PINNACLE Network™ will provide access to data management systems that translate data into clinical insights and leverages the power of the ACC’s national data registries to give practices negotiating power with payers for value-based payment systems.

“Embedding quality improvement and value-based payment in the natural flow of practice operations will be the foundation for a practice’s success clinically, financially and professionally,” said Janet Wright, M.D., the ACC’s senior vice president for Science and Quality. “By creating health information technology solutions for using ACC Guidelines and Appropriate Use Criteria at the point of care, the PINNACLE Network™ will show patients, colleagues and the health care community that we are delivering the right care for the right patient at the right time.”

The PINNACLE Network™ is powered by the PINNACLE Registry™, the nation’s first operational office-based data registry and will provide a centralized system for clinical practices to promote practice innovations and achieve clinical excellence.

The PINNACLE Registry™, designed by cardiologists, benefits from its two-year pilot phase as the IC3 Program and now will be integrated into the NCDR® to provide participants with access to both hospital and ambulatory patient-focused data. As one of the largest practice-level scientific efforts undertaken in the United States, the IC³ Program®, now the PINNACLE Registry™, contains hundreds of thousands of clinical patient records focusing on four common cardiac conditions -- coronary artery disease, hypertension, heart failure and atrial fibrillation.

For more information on the ACC’s PINNACLE Network™ visit www.pinnaclenetwork.org.

Sunday night I attended a charity event for “European Heart for Children,” a humanitarian initiative launched on Saturday by Roberto Ferrari, current President of ESC with his wife and others. The program’s purpose is to improve treatment of pediatric congenital heart disease in third world and emerging economy countries where treatment of this condition is inadequate. The program will offer training to health care providers to help them improve the care they offer, as well as educate physicians and politicians on CHD. Says Ferrari:  

“To me it's completely shocking to see first-hand that in some countries...the only hope for a child born with congenital heart disease is to go to another country for an operation otherwise they'll die. We hope that our initiative will give some hope to the children of Europe.”

Other CHD Issues
Treatment of pediatric CHD is a serious problem, not only because of the inadequate treatment in some countries, but also because of the lack of research. As a recent Wall Street Journal article put it: “Hardly any of the myriad drugs and devices developed for ... cardiovascular disease are designed with kids in mind.” Because of this, when treating pediatric CHD, “physicians often must rely on instinct, back-of-the-envelope calculations and anecdotal case reports swapped at medical meetings, instead of the more rigorous clinical evidence.” I heard from various European pediatric cardiologists and physicians here engaged in CHD diagnosis and treatment that Eastern European and some European countries have challenges in the CHD and adult CHD that still need attention locally.

Clearly, this lack of knowledge about best evidence and therapeutics regarding CHD is unacceptable. This is why the ACC two years ago began laying the ground work for a registry to look at outcomes and treatment for pediatric and adult CHD. The registry, called IMPACT (For Improving Pediatric and Adult Congenital Treatment), is in pilot phase currently but will launch officially in 2010. It will be the first national registry to provide data relating to demographics, acute management and in-hospital outcomes for patients undergoing diagnostic catheterization or catheter-based interventions for congenital heart disease. Also, it will serve as the benchmark for comparing catheter-based interventions to the more traditional surgically-based interventions currently in place. Once it’s nationally rolled-out, the pilot is going to provide invaluable knowledge about what works in the treatment of CHD and what doesn’t.

*** European Heart for Children logo. From ESC's Web site. ***

Electronic health records (EHRs) do not offer complete data to gauge performance, according to a new study in the Agency for Healthcare Research and Quality's Research Activities by Jeffrey Linder, M.D., of Harvard. Linder's research showed that EHRs were often inaccurate in determining the actual cause of a patient visit (688 encounters were billed as pneumonia, but chart reviewers found only 198 actual visits for pneumonia). A large portion of the data in the EHRs was not coded, which makes data extraction for care measures difficult.

This says to me that we’re on the right track with our NCDR registries, with their validated data elements, and with our advice that EHRs be integrated with data registries where possible.

In other registry-related news, the IC3 Program is growing by leaps and bounds! We added a whopping 100,000 patient records this week alone. Amazing. This kind of patient data in our ambulatory registry will really move the needle on quality of care.

Meanwhile, the IMPACT Registry Pilot is on schedule to launch in August for six months to test the usefulness of data elements and the feasibility for data collection. The official launch of the registry is slated for 2010. The IMPACT Registry will be the first national registry to provide data about the demographics, acute management and in-hospital outcomes for a comprehensive selection of patients undergoing diagnostic catheterization or catheter-based interventions for congenital heart disease.

Little is known about the population of patients with congenital heart disease, particularly with respect to the use and outcomes of catheterization and interventional procedures.  To date, most resources have been applied towards increasing the understanding of the anatomy and physiology of congenital heart disease, as well as the natural history of common defects.  National guidelines have been published which provide recommendations for the appropriate use of diagnostic catheterization, interventional catheterization and surgical treatments.  However, because studies performed in congenital heart disease are generally small in number, and because prior registries of congenital heart disease have been limited in scope, there is a paucity of data relating to the use of diagnostic catheterization and catheter-based interventions, and to the morbidity and mortality associated with these procedures.  Current national guidelines were derived primarily from expert opinion, and there is a strong need for data to allow optimization and refinement of the guideline recommendations.

As I discussed briefly last week, the Energy & Commerce, Education & Labor, and Ways & Means committees introduced their tri-comm health care reform bill, America’s Affordable Health Choice Act of 2009 (HR 3200, hyperlinked here for your reading pleasure). The President and others celebrated it as a landmark bill at the White House, while the Congressional Budget Office (CBO) Director, economist Doug Elmendorf, ruined their party by proclaiming the bill as an unsustainably expensive instrument that will destabilize the economy unless modified to reduce costs over time. CBO has always been the "skunk at the garden party" or worse, but this time they made House leaders and the President quite upset.  

What's In It
We strongly support access for all. But the CBO concerns are legitimate. Congress has espoused a set of worthy visions to improve quality and care coordination and efficiency, but the teeth for getting that done -- other than with the same old ineffective price controls -- aren’t yet there. A reform bill that works is certainly still possible after the debate gets going more openly. But, beyond the unspecified vision, the implementation strategies are not there. And, there are a lot of provisions in HR 3200 (many inspired by organized labor) that will alarm many of you if you read all the detail -- just understand this is a political process, and the House knows that most of that won’t survive the Senate’s scrutiny. One real concern for us is that there is no tort reform in this House version, and there probably won’t be anything to start with in the Senate health or finance versions either. 

We applaud the House for its commitment to provide access to health care to basically all US citizens, and in particular for eliminating the SGRrrr for the next 10 years. That’s huge -- $230 billion worth of what would otherwise be cuts to physicians. We praise their huge Medicaid coverage expansion, combined with taking the payment of that program away from states (which have paid on the CHEAP), and providing better payment to physicians. They put a good deal of new money into prevention and primary care, and they add money to offset physician workforce shortages. We also appreciate their establishment of a positive future Medicare physician payment updates (MEI) and favorable spending targets for updates in the future. We’re also well positioned with NCDR and the IC3 Program for their significant payment and delivery reform models, such as incentives for physicians and their expansion and improvements to the Physician Quality Reporting Initiative (although this program still lacks sufficient payment incentives ... a 2% "incentive" is close to useless for most practices). 

ACC President Fred Bove has expressed our praise of these positive elements to the three committees (that would infuse almost $300 billion of new dollars to delivery of patient care), but without praising or referring at this point to the elements of the plan that are undefined (the public option, for example), or to those we must work to amend because they are just plain bad policy (the imaging cuts, their attempt to undermine specialty hospitals, and their attempt to prohibit opting out of public coverage programs). We will work with House and Senate members to eliminate those elements -- none of which should survive Senate Finance scrutiny thankfully. The Senate will not buy the House’s income tax funding approach for HR 3200 as currently configured either. More...

A paper published in the May 19 issue of the British Medical Journal found delay in door-to-balloon (D2B) time is associated with higher mortality rates in patients undergoing PCI. (Surprise!) The study was based on data from the ACC's National Cardiovascular Data Registry (NCDR). Median D2B time was 83 minutes. The adjusted mortality rate for PCI by 30 minutes was 3.0 percent, while those with D2B times of 240 minutes had a mortality rate of 10.3 percent. The goal of the D2B Alliance for Quality (90 minutes) yielded a mortality rate of 4.3 percent.

The authors state that "their data support calls for an 'as soon as possible' standard for patients undergoing primary percutaneous coronary intervention." But how fast is too fast? Share your thoughts ...

David Blumenthal MD will be the new ONC “Coordinator.” David, a professor at Harvard and physician working with Partners in Boston, is also a friend. He is interested in ACC ideas in information systems adoption, and in the National Cardiovascular Data Registry and IC3 projects, so it will be good to have him at the helm of the HHS Office of the National Coordinator for Health IT.

Forty CEO leaders of industry met at Heart House this week to discuss important health care issues. Among the notables were Ron Williams, CEO of Aetna, several regional Blue Cross CEOs, Tony Hooper, CEO of Bristol Myers Squibb, former House Speaker Newt Gingrich (R-Ga.), and many other leaders of insurance, hospital, consumer, health care venture capitalist, consulting, and technology/industry companies. Until recently Nancy Ann DeParle was also a member of this group in her investment banking role (I actually got her plugged in to the group a few years back).

Once again, I had more than dozen overtures about renewed interest in working with ACC and NCDR on quality improvement projects, and I have set up follow up meetings to seek specific pilot concepts. Newt did a terrific job of presenting a view of where the rapidly changing science and technology environment may be heading, and he too will be meeting with us to seek ways to work with his Center for Health Care Transformation.

He emphasized that China and India dynamism is REAL; and that the increasing speed of the advancement of science will transform everything around us faster than anyone sees.

Wow. The President’s ultra-visionary speech -- and then the $3.5 Trillion budget proposal -- add up to a breathtaking agenda. On the other hand, if the economic crisis is worse than expected, or if anything else goes wrong in the world (like a Pakistan implosion, or worsened Mideast crisis, or deepening war in Afghanistan, etc), the economics of Mr. Obama’s proposals could be in the tank. That’s why it’s a bit like rolling the dice — there are big risks in the agenda, and in the budget proposal.

But, that said, why would the country not aspire again to a truly first class education system here for all citizens to build a powerful future economic base; or to a first class health system that covers everybody but doesn’t bankrupt the economy; or to a new green energy industry transformation that could further fuel a more entrepreneurial economy? This is a big vision, but a very appealing one.

The POTUS (President of the United States) certainly reiterated his support for health care reform last Tuesday night; and then he did so again Wednesday when put his money where his mouth is with the 10-year, $634 billion “reserve fund” to pay for 50 percent of the expected cost of a vastly reformed U.S. health care system. But, where does the other half of the health reform budgetary goal come from? That’s not clear, and is up to Congress to seek. This $634 billion fund will come largely from Medicare Advantage plans cuts; higher co-pays for wealthier seniors; cuts in home care; and other unspecified cuts to providers (along with new incentives for quality). Believe me, there will be devils in those details. But, we should all recognize that the present non-system IS unsustainable.

Speaking of unsustainable, what happens to the SGRrrr? That will cost over $400 billion to pay off over ten years (thereby eliminating the coming 40% cuts over that time; but by the way not increasing physician pay at all!). If we take injectable drugs costs out of Part B Medicare, the SGR pay off could be less -- supposedly about $329 billion. This amount is supposedly to be included somewhere in the budget -- but must be funded by cuts elsewhere. More...

In the final wrap up session for the 2009 Health System Reform Summit, ACC’s current presidential team commented on the findings of three break out sessions held throughout the Summit. ACC Vice President Ralph Brindis, M.D., F.A.C.C., stressed the importance of showing our willingness to work with CMS on appropriate use and our openness to conducting comparative effectiveness research by using real-time registries. In particular, we need to mature our ambulatory registry efforts, as conducted through our IC3 Quality efforts, so that quality can be measured in all places where care is provided, Ralph said.  

Attendees also used the final hour to clarify essential issues for the College, the issues and concerns we must focus on in the near future to reach consensus and better define. 

Current President Doug Weaver, M.D., F.A.C.C., gave final comments. If this conference shows anything, he said, it is that there is no shortage of ideas and there is a sense of urgency. We need to provide an imperative – although it’s unclear what that should be – for hospitals and CV professionals to use registries. If registries were used in both hospitals and practices for even just a sample of all patients, the result would be more educated members, and would serve to put quality at the front of our minds. None of this is easy, Doug said, but if we can do it convincingly, we will be ready for when patients want to know more; we will be on our way to improving quality, and we will be role models for other specialties. If we can do this, no one will stand in our way in the future.

Aneesh Chopra, health and technology advisor for Virginia Governor Tim Kaine, has been asked to participate on the Obama Transition Team to advise on health information technology (HIT). Chopra and ACC are partners in the Centra NCDR/IC3 project in Richmond.

Chopra is going to carry our message on HIT, quality reporting, IC3 and payment incentives further into the transition process where Jeanne Lambrew and others already are talking with us.

Chopra sees the potential of the IC3 program and wants to present it (and NCDR) as models of how the delivery system reforms to improve quality could proceed.

A couple of weeks ago, I talked about offsetting the decrease in payment from the Medicare 2009 Physician Payment Schedule by participating in the PQRI (in the future through the IC3 quality improvement program affiliated with NCDR). Ganpat Thakker, M.D., F.A.C.C., governor of the ACC West Virginia chapter, commented on the post: “Most of us who reported PQRI measures for 2007 did not get [an] incentive payment. CMS did not have necessary setup, and there is no appeal option. I am almost positive that we will not receive any reward for 2008 either.” The reality is that CMS lacks the capacities to run PQRI effectively -- it is a crude beginning of a quality monitoring and incentive program. A few of our larger practices got some actual reward from PQRI, but not many.

My message to all of you exasperated physicians on this topic is: Think of PQRI as an awkward baby step in the potentially good direction of substantially increasing payment for improved quality and risk-adjusted outcomes. I emphasize potentially. We are advocating to Congress and the payers for real "value" and quality-improvement reward programs with significant incentives (at least 7 – 10 percent payment increase). We are further working on Congress and insurers to appreciate the value in using our NCDR systems and the new IC3 quality improvement program to members and primary care practices to collect and populate CV performance data. If we, as the profession, are not engaged in designing and helping to implement quality improvement and reporting programs, they won’t work.

The ACC applauds all of you who made the effort to participate in the PQRI, realizing full well that it was as frustrating for most of you as the Blagojavich Senate seat selection process has been for the people of Illinois. But, since quality reporting is coming for certain, at least those of you who tried to participate are getting ready for the inevitable, and a future program that will hopefully offer real value to patients and doctors.

Please join the conversation on the topic of quality reporting and tell us what you think. Don’t use any four letter words though -- please -- if you’re a PQRI participant. We’re going to make it better.

This is the second part of this month's guest blog post from ACC Vice President Ralph Brindis, M.D., F.A.C.C. Dr. Brindis is the Senior Advisor for Cardiovascular Disease for Northern California Kaiser and a Clinical Professor of Medicine at the University of California-San Francisco, and has been a leader within the College's NCDR for years.

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CMS is increasingly looking to “Coverage with Evidence Development” as a means of improving patient value and ensuring the most cost-effective care. CMS established CED in 2006 as a way to allow the agency to offer conditional national coverage for new technologies while requiring the collection of additional patient data to supplement standard claims data, either through participation in registry or clinical trial.  CED, then, would allow and encourage the diffusion of new technology into the marketplace and the CV community through its coverage and reimbursement component. Even more importantly, if appropriately applied, it would promote the acquisition and collection of key outcomes and other patient data to allow clinicians and payers alike to best understand not only issues surrounding safety and efficacy, but also the true role of a new technology. The CED strategy has been successfully implemented in NCDR’s partnership with CMS for our ICD Registry.

Unfortunately, there often is resistance to the concept of CED by payers and also at times by practicing physicians. Payers balk at its implementation, feeling the technology is not “mature” enough to justify coverage and reimbursement even through the CED mechanism. Clinicians sometimes balk at CED implementation, feeling the technology already has a substantial “evidence base” justifying coverage through clinical trials and the premarket approval process, and that participating in a CED mandate is extra work. There are also “behind the scenes” political pressures exerted by lobbyists representing competing professional or industry interests that stymie CED implementation. The losers, unfortunately, in this situation are our patients and our CV science.

The NCDR is well positioned to play an active role in any future CED mandate – but only if payers and clinicians alike are able to embrace the terrific opportunity and mechanism for new technology assessment offered by CED.

- By Ralph Brindis, M.D., F.A.C.C., ACC Vice President

* Dr. Brindis' post is the second in a new monthly series of guest posts by ACC leadership. Check back next month to see which ACC leader is sharing his or her thoughts on health care reform!

This month's guest blog post comes to us from ACC Vice President Ralph Brindis, M.D., F.A.C.C. Dr. Brindis is the Senior Advisor for Cardiovascular Disease for Northern California Kaiser and a Clinical Professor of Medicine at the University of California-San Francisco, and has been a leader within the College's NCDR for years. 

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The College has positioned itself as a true leader in the assessment and promotion of cardiovascular quality through the development of data standards, clinical practice guidelines, performance measures and appropriateness use criteria. Data collection via the NCDR registry portfolio is another key asset that is continuing to evolve since the first registry, CathPCI, was launched in 1998.

To date, the NCDR has become an important advocacy vehicle for our ACC membership in meeting mandates from national and state governments, payers and consumer demands for quality assessment. There have also been well over 100 NCDR publications advancing the field of CV outcome research, answering questions that clinical trials cannot – particularly on select subgroups of patients typically not included in clinical trials. 

Moving forward, the FDA is increasingly turning to NCDR because of its huge potential to be a vehicle for post-market device/drug surveillance. To date, our main challenges for post-market device/drug surveillance – or for that matter, for assessing long-term clinical outcomes – is harnessing viable financial models and developing the scientific ability to accomplish true longitudinal follow-up of our patients.    

Another exciting potential role for the NCDR is in aiding the diffusion of new cardiovascular technology into health care practices. Our present approval system for small clinical trials for new devices misses opportunities for evaluations of broad-based community use of these devices in older patient subgroups and for off-label indications. Meanwhile, imaging technologies typically are released into the marketplace with very few or no clinical trials assessing their impact on clinical outcomes or even intermediate outcomes and clinical decision-making. Coverage and payment decisions for these newer procedures and technologies is complex and typically quite variable because of local CMS coverage decisions, variable private payer coverage decisions and even national CMS coverage decisions.

- By Ralph Brindis, M.D., F.A.C.C., ACC Vice President

* Dr. Brindis' post is the second in a new monthly series of guest posts by ACC leadership. Check back next month to see which ACC leader is sharing his or her thoughts on health care reform!

ACC had an exciting meeting this week with Wellmark, the leading Blue Cross-Blue Shield insurer in Iowa and South Dakota to discuss ways of collaborating on continuous quality improvement and “value” based reporting initiatives. ACC Science and Quality SVP Janet Wright, M.D., F.A.C.C., and her team led the discussions, which I discovered could be fruitful in meetings earlier this year with BCBS.  This company is one of the most progressive of the BCBS plans nationally.  And there appears to be a general interest in working with NCDR, IC3 and ACC in developing some interesting projects.