AHA kicked off its meeting with an opening session featuring AHA President and ACC member Clyde Yancy. Yancy helps lead the Coalition to Reduce Racial & Ethnic Disparities in CV Outcomes (CREDO), a joint society effort that stresses research (how accurately can we describe the present disparities?) and action (once identified, how can we target the areas to improve care?). Learn more about it from an interview I conducted with Clyde back in July.

Also speaking during the opening session was Thomas Frieden, M.D., M.P.H., director of the CDC. Dr. Frieden has been a friend to cardiology over the years through his efforts as commissioner of the New York City Health Department, where under his watch, the city cut smoking rates in teens and adults, eliminated trans-fats from restaurants, rigorously monitored the diabetes epidemic, and required certain restaurants to post calorie information prominently.

Another interesting bit on Frieden’s resume: As NYC commissioner, his department ran the largest community EHR project in the country, following a request from Mayor Bloomberg (another friend to cardiology). The project focused on getting EHRs into community health clinics to improve quality and now includes more than half of the doctors caring for patients in Harlem, the South Bronx and Bedford-Stuyvesant – low-income areas that would typically be the last to have access to such technology.

Dr. Frieden’s is an interesting approach – providing low-cost EHR and implementation support – to making sure that practice are able to implement technology. Outside of this program, you find that many offices, particularly those in small practices of one to three practitioners, face significant barriers to adopting technology. Even though the federal government is offering significant funds to help urge adoption, practices face high upfront implementation costs for health IT (we’re talking $124,000 over five years, with only $44,000 in incentives to offset the costs). That’s daunting – and many may not be enticed by the incentives knowing the cost of implementation.

However, our challenge is in reaching out to these docs to communicate the bigger picture: reduced costs and gained efficiencies—not to mention higher quality care for our patients. Getting engaged in health IT will provide the best chance of keeping smaller practices viable in the coming era of payment reform. (If you’re interested in health IT, you should come to ACC.10, where we’ll have a day-long spotlight session on the topic.) The ACC also has great resources online at www.acc.org/healthit.

***Image from Flickr (Prasan Naik)***

Congressman Gordon (D-Tenn.) has convinced House Energy and Commerce Chair Henry Waxman (D-Calif.) to allow his medical malpractice amendment in H.R. 3962. Gordon’s amendment would facilitate “certificate of merit” systems in states that achieve the reductions in premiums claimed in Ohio, Michigan and a few other states when such a program is designed and implemented properly. But the good Congressman has informed us he’s interested in a broader tort reform agenda, and we should help make it happen! During these tough and financially tight times, a reduction in med-mal premiums could be a godsend.

The other idea we are exploring is to provide a set of protections and/or safe harbors for those physicians who achieve the health IT-related “meaningful use.” I am working with a coalition (that we are helping to create) to explore this idea. The meaningful use process of the Office of the National Coordinator (ONC), David Blumenthal, MD, builds on allowing the federal stimulus benefit dollars to go to only those doctors who qualify as “meaningful users” of health IT. Basically, meaningful use will involve phased-in application of electronic health records, e-prescribing, clinical decision support systems, privacy and security protections, computerized physician order entry, and perhaps a few more elements of an e-office. If incorporating health IT could be accompanied by a significant reduction in medical malpractice costs (even if only for Medicare and Medicaid patients), it would be an additional big incentive to go electronic (not to mention being able to receive over $40,000 from the feds to help do it).

The PINNACLE Network™ concept is in fact the pathway to meaningful use for cardiologists and other physicians who care for cardiovascular patients. This is all happening rapidly, and we will talk to Congressman Gordon and others about expanding on his idea and giving the trial bar a run for their money before this reform process is completed.

And here’s an additional plus: This week, Chairman of our Working Group on Malpractice Insurance Bill Oetgen, M.D., F.A.C.C., and I met with the CEO and CMO of the nation’s largest physician-owned medical malpractice insurer, the Doctor’s Company. We discussed some exciting ideas that could reduce premiums for cardiologists at the same time reducing the risks of adverse events and patient safety-related incidents. This was a dynamite meeting.

Photo: http://www.flickr.com/photos/mindgutter/ / CC BY-NC-ND 2.0

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.

The ACC recently came out with this great CVN video highlighting our recent Legislative Conference. In the video, I point out that the proposed cuts, the final version of which are soon to be announced, are distracting us from pursuing other noble health care reforms, such as promoting quality, reforming malpractice laws and increasing access. I've listed a couple of possible options for what else we COULD be focusing on right now if it wasn't for the Rule, but add your own suggestions in the comments section below.

Kaiser Permanente’s CEO George Halvorson called for a celebration this month for the successes of a program launched decades ago they call Archimedes. It is a computerized artificial intelligence system that creates models of the human body and then projects the probable impact of care and treatment approaches. Archimedes has been used to do a couple of clinical trials and ended up with results that matched the actual clinical trials done on live patients. They routinely use it to improve care. And it works.

One of their primo researchers, David Eddy, M.D., just did a large scale test of Archimedes relative to the prevention of heart attacks and strokes. One of the scenarios that the researchers ran through Archimedes looked at what might happen when a mixture of prescriptions that science has suggested are helpful in CAD was combined to prevent heart attacks and strokes. (The drugs considered were aspirin, Lisinopril, and a statin). There was no tool to do that study. So they used Archimedes and ran a computer experiment with their own patient database.

Archimedes predicted that a "bundled" prescription of heart protective medications would reduce the risk of heart attack and stroke for the Kaiser Permanente high-risk populations by 71 percent. They missed by a bit. Over the course of three years, the three drug program actually prevented 1,271 heart attacks and strokes. That reduced the occurrence of heart attacks and strokes for the covered population by 60 percent instead of the 71 percent projected by the system.

300 media outlets have picked up this story. The world now knows that the simple combination of medications in KP's Aspirin-Lisinopril-Lovastatin (A-L-L) initiative -- this will have a potentially greater impact on emerging nations that can’t afford interventions I suspect. It’s very interesting stuff. And, they’re spreading the option to participate across their entire population, and 250,000 have signed up to try it with disease management and/or early risk factors.

It’s impressive -- they’re using predictive modeling, targeted member outreach, and computer-supported care to get real results. Hats off to KP and Archimedes.

*** Image info: http://www.flickr.com/photos/gi/ / CC BY-SA 2.

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.

This month’s post comes to us from past president of ACC’s Virginia Chapter, John Brush, Jr., M.D., F.A.C.C. In addition to serving three years as Chapter president, Dr. Brush practices at Cardiology Consultants, Ltd., in Norfolk, Va., and is an Assistant Professor of Clinical Internal Medicine at Eastern Virginia Medical School. He also has been a leader in quality improvement, assisting ACC efforts with “Door-to-Balloon: An Alliance for Quality” and the IC³ Program, and as a member of ACC’s Clinical Quality Committee.

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In the current health care reform debate, there has been considerable discussion about comparative effectiveness. This method of evaluation could provide valuable information on the relative value of competing drugs, devices and treatment strategies, which in turn could improve outcomes, efficiency and satisfaction. Critics are concerned, however, that comparative effectiveness could be used to deny coverage, squelch innovation and ration care. Because of these concerns, some stakeholders forcefully argue that comparative effectiveness evaluations should be totally devoid of cost considerations.

But how can you compare competing treatments and ignore costs? To use heart failure as an example, could you really compare the relative effectiveness of ACE inhibitors and left ventricular assist devices and ignore the wide difference in costs between the two treatments? And isn’t the public’s desire to gain “more bang for the buck” what’s driving health care reform in the first place?

The Case for Cost Effectiveness
Cost effectiveness research is difficult and has recognized limitations. Yet no method of research is perfect or definitive. Although cost effectiveness research has some limitations, we should not reject the useful information that it provides for comparative effectiveness analysis.

There is a compelling need to contain costs in order to extend health care coverage universally in America.  Comparative effectiveness research will give policy makers important information that will help set priorities for spending.  As with clinical practice guidelines, comparative effectiveness analysis should inform, but not dictate clinical decisions.  Personalized decision-making for individual patients should always trump broad policy recommendations.

Comparative + Cost Effectiveness
Comparative effectiveness research and analysis will require a disciplined approach.  Comparative effectiveness research should be a transparent scientific process, absolutely free of economic influence.  Advisory boards that oversee this research and analyze the results should be shielded from undue political influence.  For years, NIH has distributed billions of dollars in funding, using established methods that are generally respected as fair and non-biased.  Similar independence and discipline can be established for overseeing comparative effectiveness research and analysis. 

Comparative effectiveness research using cost considerations should be a two-stage process.  The first stage should pertain to relative clinical effectiveness and the second stage should deal with costs.  For competing treatments with similar clinical effectiveness, no further cost effectiveness research is needed because direct cost comparisons would be simple.  But in comparisons where one treatment is more effective, careful analysis of costs will be necessary to estimate the monetary value of the increased effectiveness.

Constructing a Firewall against Undue Influence
To maintain the integrity of this process, and to shield the process from political and financial influence, a firewall should be constructed between comparative effectiveness evaluation and insurance coverage decisions.  The funding level for coverage is a political or a business issue, not a scientific issue.  The funding level for Medicare is up to Congress, and, ultimately, to taxpayers.  The funding level for private health plans is up to the purchasers and benefit design managers.

Comparative effectiveness analysis can be separated from coverage decisions by borrowing the method used in the process of grant funding:  

• When judging grants, the judges evaluate the grants based on the scientific merit of the grant, without consideration of whether the grant will actually receive funding.
• Grants are graded on a relative scale.
• Top grants that fall within the funding range receive a grant.

Is that rationing?  Perhaps so, but this explicit method of determining coverage seems more rational than the current method for rationing where we deny care to nearly 50 million Americans because they lack employer-based insurance or don’t meet the criteria for Medicare or Medicaid.

The device and pharmaceutical industry is predictably worried about comparative effectiveness.  Undoubtedly, comparative effectiveness would provide pressure on pricing, which is generally lacking when providers and patients pass on costs to third party payers. Transparent comparative effectiveness would give consumers of health care an opportunity to shop for greater value, which will help contain overall costs. 

We Can’t Have it All
This is the unfortunate truth: the growth in health care spending is unsustainable and is making health care unaffordable for average Americans.  In health care, we can have nearly anything we want – we just can’t have everything we want.  Because of escalating costs and limited funding, we need mechanisms to differentiate medical treatments with high value and those with little incremental value.  Without a method to objectively analyze the relative value of treatments, the costs of medical care will continue to rise to unaffordable levels.

-- John E. Brush, Jr., M.D., F.A.C.C.

* Dr. Brush’s post is part of a 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!

*** Image from morgueFile (jdurham). ***

The HHS Health IT Policy Committee (HIT PC) held its first meeting last week under the direction of (our friend) David Blumenthal, formerly of Partners and Harvard and now Obama’s National Coordinator for health IT in HHS. The HIT PC is going to develop policy recommendations and health IT dollar-distribution strategies for those who show "meaningful use" of an EHR.

That’s $20 billion worth of power theoretically, but only $2 billion of the funding is actually in Blumenthal’s direct oversight. Blumenthal wants to spend at least $300 million training health care workers in how to deploy health IT. He will also deal with privacy insecurity issues, and hire a chief privacy officer; but he seems open to standing up to the bludgeoning he may experience by suggesting a unique patient identifier (UPI) is needed to help track patients in the chronic disease continuum. We strongly agree, David.

The big coming arguments of the HIT PC will be around what the "meaningful use" definition actually means. They have a workgroup to help define that, as well as workgroups on privacy and safety, and another one on interoperability standards. Keep in mind that if your practice isn’t deemed 'meaningful,' you ain't gettin' any money here. It’s worth paying attention to. Believe me, we will not miss those meetings or fail to get involved with the workgroups Blumenthal is forming.

***Image from Flickr (Prasan Naik)*** 

Kaiser Permanente has substantially improved the heart attack survival rate for its members in Colorado through an innovative program that links coronary artery disease patients and teams of pharmacists, nurses, primary care doctors and cardiologists, with an electronic health record (EHR) and advanced clinical care registry.

George Halvorson, CEO of Kaiser, underscored that technology and treatment innovations alone are not enough.  

“It was not newer or more expensive treatments, but an integrated approach to deliver the right care at the right time. Maximizing information for the clinician means optimizing care for the patient."

The Kaiser pilot integrated front-line nursing and pharmacy teams that worked with cardiovascular patients and their physicians. The program achieved the following results:

• Patients had an 88 percent reduced risk of dying of a cardiac-related cause when enrolled within 90 days of a heart attack, compared to those not in the program;
  
  
• The number of patients meeting their cholesterol goal went from 26 percent to 73 percent, and;
  
  
• The number of patients screened for cholesterol went from 55 percent to 97 percent.

Proof positive that technology and coordinated team-based care can make a change for the better in the quality of cardiovascular care.

The health care reform agenda is moving from high gear to warp speed. The pace in Washington continues to be increasingly dizzying, with hearings, meetings and spontaneous feedback sessions too numerous to mention -- or to attend.

Busy, Busy, Busy
Here's what we DID manage to squeeze in last week:

• Two meetings with Senate Finance Committee Chair Baucus (D-Mont.) and Committee staff about their recently released health care reform recommendations
  
  
• Meetings with House Majority Leader Steny Hoyer (D-Md.) and Sen. Majority Leader Harry Reid (D-Nev.)
  
  
• A high-level meeting at CMS with the top people under the incoming secretary to lay out our ideas on how independent practices could participate in gainsharing and quality improvement pilots
  
  
• Listened in to Kathleen Sebelius' first testimony to the House Ways and Means Committee
  
  
• Attended one of the first meetings of the health IT advisory committee on stimulus spending and IT strategies of the Obama administration

All this is just what we did before breakfast on Monday. Well, actually, it all happened before Wednesday. We also met with the CEO of GE, Jeff Imholt, who presented his company’s impressive health reform strategy -- they call it ‘healthyimagination,’ and it involves appropriate use criteria and cost savings ideas, in addition to continuing to invest in science and technology. I met with PHRMA CEO Billy Tauzin and Chair David Brennan, also CEO of Astra Zeneca on their strategy for reform. They emphasize promoting the patient-physician relationship and professionalism and lowering patient co-pays to increase adherence.

Impressions
So what are the impressions at the end of this week? More...

As part of our Year of the Patient, the College is in the process of developing a pilot project aimed at increasing patients’ adherence to medication. The long-term goal is to improve outcomes by identifying and advancing a new evidence-based practice model that uses EHR and e-prescribing history.

We historically have not taken advantage of data on medication history. In this pilot project, we’ll make minimal modifications to e-prescribing and EHR software, allowing care team members to easily access medication history and use it to identify non-adhering individuals.

The project also will test the effects of two novel interventions to improve adherence:

1. Having a dedicated care team member in the cardiology practice designated as a "medication specialist."
   
   
2. Offering a set of tools the medication specialist and physician can use to prompt and educate patients.  The tools include online interactive patient education, pillboxes, and physician communication tools and techniques. 

Finally, the ACC will develop a reproducible, evidence-based model that can be used by other practices nationally. Look for more on this pilot to come!

*** Image from Flickr (macwagen). *** 

All the major participants in the governmental reform processes — Congressional Committees and the White House — are putting words to their ideas for health care reform at a frenetic pace (just look at the media coverage). ACC has been asked for feedback again this week from all of these key determiners, including intense meetings with the Office of Management and Budget team and with the Senate Finance Committee staff leadership.

The Senate Finance Committee has begun their debate three buckets of health reform issues earlier this week: delivery system, coverage and financing. Of course, most of our issues fall under delivery system reform, but financing is where it will all happen or not. The roundtable included input from payers, think tanks, providers, consumer advocates and business. WE have made sure our views are on the table. Most of what happens is behind the scenes -- the window dressing is just to make sure the media knows things are happening.

Legislation is still likely to officially emerge from these almost-occult processes in May or June. Rumors abound about what it might look like.

What Reform Could Look Like
Reforms will likely be proposed and funded over three time phases: immediate changes (in the next one to three years); intermediate reforms (over two to five years) and longer-term reforms (over seven years). In each phase, the delivery system, payment models, financing structures, and administrative and regulatory systems will undergo fairly dramatic change. The administration reiterates the future health care system should preserve choice, should cover all citizens, should promote quality and should do all this while slowing the rate of cost increases. More...

I did an unhealthy red-eye and 24 hour total stay in Paris this week to make a keynote presentation on our vision for health IT and on how registries could greatly improve quality here in the US and internationally at an invitation-only meeting organized by Sanofi and others in Paris.

Europe and other countries are behind our progress in these regards. I imparted a lot and also learned a great deal from other presenters, including about the growing interest of consumer groups in our activities, and about the growing interest in improving medication adherence everywhere. Some of the best results in that latter category seem related to pilots where health insurers pay for the outpatient drugs 100% if adherence is measured and tracked. 

Everybody, however, interprets the recent JAMA article on relationships with industry as potentially spoiling any genuine partnerships that might otherwise develop to improve patient care via registries and professional societies.

Merck and other companies are also hard at work on researching how to improve adherence. We have learned a lot from their sharing of their research, along with ideas from the Veterans Association, MedCo, and others -- who like us, know that in addition to improved prevention strategies, adherence has to be a critical priority if we intend to reduce morbidity significantly in the near future. This will important in preventing readmissions as well.

*** Image from Flickr (macwagen). *** 

Gene L. Dodaro, Acting Comptroller General of the United States and head of the U.S. Government Accountability Office (GAO), last week announced the appointment of 13 members to the Health Information Technology Policy Committee, a new advisory body established by the American Recovery and Reinvestment Act (Stimulus Bill). The committee will make recommendations on creating a policy framework for the development and adoption of a nationwide health information technology infrastructure, including standards for the exchange of patient medical information.

Unfortunately, none of the GAO appointees are ACC members, but the good news is we count many of those appointed as friends. Drs. Paul Tang (Palo Alto), Mark Probst (Intermountain), David Bates (Partners and the Brigham), and David Lansky (Pacific Business Group on Health) have all worked with us on issues. And the ‘privacy’ and consumer reps appointed seem to be reasonable people.

There is another chance to be involved here, and in a bigger way, when the Office of the National Coordinator on Health IT in HHS appoints their own Advisory Committee to work with the new National Coordinator, David Blumenthal MD, another friend of ACC. Plus, MedPAC and various public-private bodies, including CCHIT, Connecting for Health and others, also will be important.

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.