I loved President Obama’s challenge to the nation and the Congress in his State of the Union last week that we invest in science, innovation, and education to effectively take on the competition of China, India, Brazil, and EU to remain on the cutting edge of leading the future -- e.g. to rise to address our ‘Sputnik moment.' That was leadership and creative thinking.

But what was weird to me was his failure to apparently embrace any of the advice of his Deficit Commission or to suggest how to reduce the national debt before it chokes us out of global competition. He did promise on his part to hold government (civil service) spending flat for 5 years, other than funding his ‘innovation’ challenge.  

I heard between the lines a general indication from both sides of the aisle that increasing reimbursements and fixing the SGR are not likely to be high on the Senate’s or the President’s real list of priorities. It’s hard to paint fixing the SGR as a way to promote innovation -- but indirectly it is in that the profession and the Congress remain hypnotized and constantly preoccupied on the SGR albatross around our necks, rather than on designing new quality-incentivized payment reforms to innovate health care delivery. 

Obama was strong on keeping the Affordable Care Act (ACA) moving (his potential for re-election looking better now than in 2010 means he might have 6 years left to make it work), but he expressed openness to amending the ACA in partnership with Repubs.  He emphasized expanded access, drug funding, insurance reform, and $250 billion in savings. And, he unexpectedly promoted tort reform! That’s great, even though he won’t support caps on non-economic damages. But, we must jump on the opportunity of proposing significant tort reform.

David Cameron is “streamlining” the UK National Health Service budget, and colleagues there know reimbursement will be flat or down; and the Netherlands, Ireland, Spain, and other EU countries are slashing physician payments by over 30%. FFS payment here will be in jeopardy here -- only payment reforms that go after bundled and global population based payment gainshare options seem to be possible routes to ongoing viability.

So, what does this all mean? Well, in summary, my final advice on the implications of the State of the Union and Congress’ current plans is: Gird your loins.

ACC.11 and i2 Summit 2011 meeting co-chairs are at Heart House today (or at least some of them are ... DC got quite the snow storm last night and not all could make it in) to discuss details about our upcoming meeting in New Orleans, April 2-5. The meeting co-chairs will be discussing the LBCT submissions and making decisions about what science will, and won’t, make the cut for presentation. Selected LBCTs represent the best of the best: the studies most likely to completely alter clinical practice. The submitted trials are judged on the impact and novelty of their research; rigor of the design/methods; major clinical endpoints; and the quality of the statistical plan.

In addition to presenting their trial, presenters also participate in an unstructured Q & A session called “The Trialist Is In.”  These informal sessions are designed to foster greater interaction between participants and trialists. The Trialist Is In sessions at ACC.10 were popular, well-attended and a marvelous opportunity to “touch the sleeve of the master.”

Finally, a plug for how to stay in touch between now and April: Join the ACC.11 & i2 Summit Community on CardioSource. The community is meant as a space to discuss the science, connect with other attendees, and hear from the meeting co-chairs and other faculty. You can start by introducing yourself in the Introductions forum! Also, follow @ACC_11 on Twitter for updates if you’re on Twitter.

The ACC recently established a new council to inform the College on academic and research concerns with the mission of “advocate[ing] for high-quality cardiovascular care, education, and research by serving as a voice of the academic cardiovascular community.”  The Council on Academic Cardiology held its first meeting during the American Heart Association’s Scientific Sessions in November. While in Chicago, the council’s chair, Joseph Hill, F.A.C.C., Ph.D., and the College’s president-elect, David Holmes, F.A.C.C., recorded an interview for CardioSourceVideoNews. In the interview, Drs. Hill and Holmes discuss the new council’s mission and how it will provide the College with the academic perspective on significant issues such as education, training, and research support as well as the importance of science and education to the entire cardiovascular community and some of the activities the council has planned. View the video.

Academic health centers (AHCs) are a critically important part of the U.S. health care system. Not only do they provide a significant amount of important tertiary and quaternary health care, but they also educate our physicians and other health care professionals, and do an enormous share of our medical research. The AAMC has been generating a lot of advocacy background to protect AHCs in an era of certain cost reductions, noting that AHCs estimate that they’re paid $0.75 on the dollar for Medicare services (big losses) and less than $0.60 on the dollar for Medicaid (bigger losses). NIH relies on AHCs for major research activities, and it would be a very ugly mess if we’re unable to train the next generation of health professionals to meet the expanded access to care that is occurring in health care reform. AAMC President Darrell Kirch MD has been doing his best to educate Congress about the threats to AHCs and about the growing shortage of health care professionals to meet the nation’s future needs.

I heard a brilliant presentation by Duke Health System’s President and CEO Victor Dzau FACC, who articulated parallel concerns for his prestigious institution very clearly. But Victor intends to act to re-invent the institution before it falls victim to radically changing circumstances.  In anticipation of the mega-changes all AHCs will face in the next decade, Duke has already been an innovator in these regards, restructuring their delivery system to vertically integrate ambulatory and inpatient care across the entire region they serve, and bring many hundreds of new physicians and community providers into their expanding networks. They have built many new ambulatory facilities spanning out into the community, as well as a number of “focus factory,” non-teaching surgery- and procedure-oriented centers. They are working on novel community care, quality network, and self care systems, including the Community Care of North Carolina system (CCNC), which offers a per-member, per-month payment subsidy for medical practices to coordinate care similar to the patient-centered medical home concept.

Dzau and Duke leaders, along with counterparts at Johns Hopkins, believe it will be necessary to streamline and re-organize the way research is conducted, along with achieving greater efficiencies in the entire health care delivery process. Duke is one of a number of AHCs across the country that is also reaching out globally to provide needed education and research services to the developing world, which not only provides needed services in such areas but also brings some margin back to the mothership in these difficult economic times. The ACC hopes that other AHCs are embarking upon similar innovative means to protect their viability in the tougher times just ahead.

Health blogger Kevin Pho, M.D., wrote recently about radiation risk from CT scans, and how the “best way to help curb the rampant ordering of these tests” is by educating patients about the radiation stemming from the tests. Pho cites an Annals of Emergency Medicine study finding that patients underestimate their radiation risk (no surprise there), disagreeing with the statement that CT scans would up their cancer risk, and ¾ not understanding the differences in radiation between CT scans and traditional chest x-rays. Pho writes:

“The best we can hope for is to explain to patients the risks and benefits of ordering such scans, and together come up with a shared, informed decision. Of course, our health system isn’t set up for such conversations. There is much more incentive — from a reimbursement, malpractice, and customer service standpoint — to simply order the test.”

I agree with Pho on his point that educating patients about the radiation risks involved in ordering CT scans is of utmost importance, but we must balance this concern about radiation with making sure patients get the tests that they need to diagnose and treat a life-threatening condition.  Cardiovascular disease continues to be the number one cause of morbidity and mortality in the U.S. Meanwhile, risk of cancer due to radiation exposure, although a real problem, must be properly balanced against the benefits of our imaging technologies.

Because of the delicate balance that must be maintained, the ACC has taken a multi-pronged approach to ensuring radiation safety, including:

1. Setting standards through laboratory accreditation programs, appropriate use criteria (AUC), clinical practice guidelines, and other standards documents;
   
   
2. Developing requirements for training programs and competency, including how to minimize radiation doses during testing and procedures; and
   
   
3. Implementing quality improvement programs aimed at lowering the dose for each scan or procedure performed. Approaches to minimizing doses include using AUC to eliminate unnecessary scanning procedures; following the principle of "as low as reasonably appropriate" with respect to radiation levels; displaying dose information wherever studies are done; and encouraging facilities to monitor delivered doses and compare them with benchmarks.

Combining these three approaches with patient education is the best way that we can reduce radiation risk while still making sure patients get needed tests. Maybe the only way.

Check out Pho’s full post here. For more on ACC’s views on radiation safety, read a JACC’s President Page I wrote with ACC leader Pam Douglas, MD, FACC.

The intern-resident-fellow work hour issue keeps on being at the forefront of controversy. A recent survey of residents appearing in NEJM found that 51% of residents agreed that new rules from Accreditation Council for Graduate Medical Education (ACGME) would improve their quality of life and well-being, but nearly half also said they would hinder their education. Beginning in July, residents’ duty hours are limited to an average of 80 hours /week, with first-year residents limited to 16-hour days and second-year residents to 24-hour days.

At the Association of American Medical Colleges (AAMC) meeting in November, there was a panel discussion entitled “The New ACGME Standards: A Call for Fundamental Change in Graduate Medical Education” which included Tom Nasca MACP, CEO of ACGME and UCSF CEO Mark Laret as panelists. Colleagues I highly respect and trust noted at the meeting that the medical students, residents, and fellows in attendance at the AAMC are thinking the new restrictions go too far.  During the question and answer period, a hematology oncology fellow from Memorial Sloan Kettering shared a concern -- with other trainees agreeing -- that there is a lack of pedagogical evidence to support the further work-hour restrictions being proposed, raising the question as to whether trainees in the current environment will be competently trained as practicing physicians. What are your thoughts on the restrictions?

In a continuation of the tort reform theme, Health Affairs recently featured a study finding that physicians’ fear of malpractice does not appear to be correlated with their actual risk of being sued. Senior study author David Katz, MD, associate professor of medicine with University of Iowa Health Care, said:

"We found that both generalist and specialist physicians fear being sued for malpractice even in states where their risk of being sued is relatively low. One likely explanation is that physicians' concerns about malpractice are driven more by their perception that the malpractice tort process is unfair and arbitrary and less by their actual risk of getting sued.” [emphasis mine]

The study found that, in general, physicians’ concerns about malpractice were not reduced by malpractice reforms implemented in some states. They write: “States that had established caps on total damages or abolished joint-and-several liability were associated with modestly lower levels of physician malpractice concern.” Two reforms – split recovery and patient compensation funds – were actually associated with higher levels of concerns among physicians. Additionally, collateral-source rule and periodic payments reforms were not significantly associated with any change.

I think this brings up some interesting points.  If malpractice reform can’t reduce the fear of being sued, what can? Despite the article’s somewhat negative outlook (the authors conclude that the only way we can reduce costs through malpractice reform is to tie malpractice reform to bundled payments), I do think tort reform can go a long way in helping defensive medicine. The ACC has a couple of things in the works to help members reduce risk. For one, the ACC is working on tort reform legislation. Secondly, we have a new Risk Management Institute that uses both educational tools and other ways to reduce risks of suits and costs of coverage for our members.

What do you think can help to reduce defensive medicine costs?

Mainstream media covered an interesting observation on the Affordable Care Act (ACA) recently regarding high-risk patient coverage. The part of the ACA that was enacted almost immediately this year was to provide access through high-risk pools for people who are too ill to easily obtain or afford health insurance. The pools were set up in about half the states pretty quickly (some already had such a pool); states that chose NOT to establish them could then refer residents in need to a back-up federal pool for coverage of states without their own special high-risk health plan. The high-risk pools were only to be needed until the ACA is fully implemented in 2014, when such patients will be covered in other ways, mainly through the proposed state exchanges. Twenty-three states and the back-up federal pool were in effect this past fall.

Republicans, insurers, state governments, and many policy observers predicted when the pools were established that the $5 billion that Congress has devoted to the program for the next 3 years was far too little money, and would run out way before 2014. But, here’s the surprise: hardly anybody is signing up! Last spring, Medicare program's chief actuary predicted that 375,000 people would sign up in 2010, but only 8,000 have enrolled nationwide (only Colorado's plan is close to its forecast enrollment for some reason).

Federal health officials contend that the new plans are just ‘experiencing expected growing pains,’ and will take time to let people know they exist and to get actuarial experience and data to adjust prices and benefits to be attractive. State directors of the pools in part agree, but say the premiums they must charge are unaffordable for most of the intended beneficiaries. They also blame the Republican threats to overturn the law or de-fund it as deterrents to people who would benefit, and people think they need to wait and see if these plans survive.

Some patients credit the new pools as already having saved their lives. Others say the premium costs are more than they could possibly afford, and are a big disappointment.

The feds will pump money into advertising this year to let people know the plans exist; and premiums are being adjusted downward to make them more affordable in many regions. If we build it will they come?  I wonder. What are your thoughts on the high-risk pools?

Yesterday, an article was released in JAMA that will, without a doubt, have major implications for physicians and hospitals in their evaluation of their practice patterns related to ICD implantation for primary prevention of sudden cardiac death. Using data from ACC’s NCDR (National Cardiovascular Data Registry) ICD Registry, the article’s authors completed a retrospective analysis of 111,707 patients enrolled in the registry between 2006-2009 to examine if ICD implantation followed evidence-based based practice guidelines. The ICD implant was considered non-evidence-based if one of the following criterions was present:

• MI within 40 days of the implant;
• Coronary bypass graft surgery within 3 months of the implant;
• New York Heart Association class IV heart failure symptoms; or
• Newly diagnosed heart failure.

Researchers found that ICD implantations were not in accordance with practice guidelines in 22.5% of patients, most commonly because of newly diagnosed heart failure (62%) or an MI within 40 days (37%). The risks of in-hospital death and complications were significantly lower when the ICD implant was consistent with practice guidelines (0.18% and 2.4%, respectively) than when it was not (0.57% and 3.2%, respectively). CardioSource has a journal scan of the article for more details.

Implications
Although the article offers sobering findings, it also highlights the extreme value of registry participation. Participation in the ICD Registry is mandated by the Centers for Medicare and Medicaid Services, and every U.S. hospital that implants ICDs for the purpose of primary prevention of sudden cardiac death participates. The ICD Registry recently has developed the ability to connect longitudinal Medicare administrative data of ICD patient outcomes -- such as mortality and repeat hospitalizations -- with our in-patient hospital registry data. This longitudinal follow-up assessment will extent our knowledge base substantially. It will be particularly fascinating, for example, to assess longitudinal outcomes for the patients highlighted in this week’s JAMA study.

Many colleagues have already written correctly about the important role of physician judgment that, at times, may overrule a practice guideline recommendation; the litigious concerns involved physician-decision making; and issues surrounding accuracies of the clinical subtleties that the registry may not fully assess related to clinical variables for the decision-making in ICD implanting. What we all cannot overlook, however, was the marked variability between hospitals related to ICD implantation inappropriateness ranging from 0% to 40%! Even to the skeptics among us, this implies a tremendous opportunity to improve cardiovascular care.

As the famous quote goes: “If you can’t measure it, you can’t manage it.” NCDR is the measurement system for managing the quality of care we provide patients. The evaluation of what clinicians are doing through the collection of the data can help us not only better learn practice patterns and have a better understanding how clinical practice guidelines are applied but also potentially extend our knowledge and evidence base.

I’ve been involved in the NCDR since its inception, serving as its chief medical officer for a number of years. We may not like what this study uncovered, but I think all of us can agree that without this data, we would not be able to move forward as a high-quality specialty. This data gives us the chance to improve: for providers, that means practicing greater adherence to our practice guidelines, and for the ACC, that means using this data to understand how guidelines are used in clinical practice and to improve the strategies we offer our members to implement the guidelines in everyday practice, such as the development of useful continuous quality improvement programs. We are proud of the NCDR ICD Registry for the incredible value it offers to the medical community and our health care system as a whole in improving quality of care for our nation's patients.

For additional perspective on the study, read a blog post by ACC Board of Trustees member and Hospital to Home leader Harlan Krumholz, MD, FACC, on the Forbes Science Business Blog. His blog is a  superb piece and goes to the heart of the matter for most of the doctors doing the inappropriate implanting. Their desire to serve their patients to the best of their ability at times blinds them to evidence-based recommendations.

Also, don't miss the ACC/HRS joint statement. 

I look forward to reading your responses and counsel in the comment section below.