The New York Times published an op-ed piece from former OMB director Peter Orszag suggesting that physicians who follow evidence-based guidelines to care for patients should be immune from malpractice suits. Several letters to the editor the following day opposed the concept, but at least the topic of malpractice reform as a means to help “bend the curve” of medical care expense in the U.S. was raised. AMA had a letter in support of the concept. If you did not see the piece, definitely check it out and leave your thoughts below.

This post is authored by Christopher P. Cannon, MD, FACC, editor-in-chief of the Science and Quality section of CardioSource.org and an associate physician in the Cardiovascular Division at Brigham and Women's Hospital in Boston. He also is an associate professor of medicine at Harvard Medical School and a senior investigator of the Thrombolysis in Myocardial Infarction (TIMI) Study Group.

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For the first time in over 50 years – we have a new oral anticoagulant to use in place of warfarin!  This past week, the FDA approved the oral thrombin inhibitor dabigatran (Pradaxa) for the prevention of stroke or systemic embolism. The approval was based on the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial, which found that dabigatran, an agent that does not require monitoring of the INR, was as safe and effective, and at the 150-mg twice daily dose, actually superior to warfarin.

Although few people were surprised by the approval of the drug, what was surprising was that only one of the two doses tested in the RE-LY are the doses that the FDA approved. The RE-LY trial tested the effectiveness of 110- and 150-mg twice daily doses. However, the FDA approved only the 150-mg dose (with 75 mg pills also available) – but not the 110 mg dose.

I queried the FDA, and they wrote back to me saying they would soon post an explanation of their rationale. They did explain the 75-mg dose (which wasn’t included in the RE-LY trial) as wanting a treatment option for patient with severe kidney impairment.

SO – what about the 110-mg b.i.d. dose? This dose was seen to be as effective as warfarin. The topline result from RE-LY found that dabigatran 110-mg vs. warfarin had a relative risk of 0.91 and 95% confidence interval [CI] of 0.74 to 1.11 (p<0.001) for noninferiority. So the trial has a pre-specified endpoint and analysis plan, and meets it with p<0.001, and yet FDA doesn’t approve it? I honestly don’t understand. The key is that there is a lower rate of major bleeding: 3.36% per year for warfarin and 2.71% with 110-mg of dabigatran (p = 0.003) and a significantly lower rate of intracranial hemorrhage! So, we have a drug regimen that is equivalent to our current treatment – but safer, and doesn’t require monitoring. With the FDA’s key focus on safety, how could they not approve this safer dose of the drug?

Thoughts on Why
For now we don’t know why. The agency could say that the 150-mg dose is better, so there is no need to approve a dose that is not as efficacious, but I would counter that is true for a lot of medications. Atorvastatin has an 80-mg dose that is proven to be better than 10-mg, but all doses are still on the market!

Some have said that because it was an open-label trial (actually partially blinded to the dabagatran dose) that this makes it harder to be 100% sure that there was not bias in assessing bleeding. But that really doesn’t hold either since the dose of dabigatran was blinded and, thus, neither the physicians nor patient knew which dabigatran dose they were getting and yet the FDA approved the higher dose. We will learn more soon, but I hope that this dose can continue to be discussed and ultimately approved.

The reason is: I think about all the patients I have treated in the past month with AFib – they are all very old, and most have risks for bleeding. For example, I admitted a patient recently for AFib and bradycardia. He is over 90, has trouble walking and falls often. He has been treated with warfarin, but the team admitting him was fearful that he might fall and get an intracranial hemorrhage. Wouldn’t it be nice to have a safer dose for this patient? I could name many other patients just like him – probably half of my Afib patients have stories like this where having a safer alternative to warfarin would be the optimal choice for therapy.

FDA apparently will soon offer some insight, but I hope that the 110-mg dose will continue to be discussed. It is available in Europe – and one physician from Turkey spoke to me yesterday at the Cardiometabolic Health Congress, where he said has over 100 patients on the 110-mg dose – and he has been very happy with their clinical course. I just hope that all the trial nit-picking can end and people look at the big picture and see this new treatment option for what it is worth – a major new advance in treating patients with AFib.

Why do you think the FDA did not approve (at least yet... people know I am ever the optimist) the 110-mg dose?

This post is written by Allen J. Taylor, MD, FACC, chair of the writing committee for the new 2010 Appropriate Use Criteria for Cardiac Computed Tomography and a professor of medicine at Georgetown University.

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The ACC and the Society of Cardiovascular Computed Tomography (SCCT) yesterday released updated appropriate use criteria (AUC) for cardiac computed tomography (CCT), which incorporates the many advances in CCT technology that have been made and the explosion in new clinical data since the document’s initial release in 2006.

The CCT AUC were created by developing clinical scenarios in which CCT might be a diagnostic option. The scenarios are then rated as appropriate, inappropriate or uncertain by an external panel of technical advisors. In 2006, the AUC for CCT include 39 clinical scenarios. In this 2010 update, we’ve include 93 different scenarios to cover the range of presentations a clinician might be faced with. The clinical scenarios include two tests: 1) CCT angiography that uses contrast dye and 2) non-contrast CT scanning for calcium scoring.

Overall, 35 indications were appropriate, and 29 each were uncertain and inappropriate. Comparing the 2006 and 2010 criteria, about 25% of the previously rated clinical scenarios showed an increase in their appropriateness rating. Some general findings in the 2010 ratings:

• CCT angiography is appropriate for diagnosis and risk assessment in patients with symptoms of possible heart disease who have low to intermediate risk of a heart problem, or uncertainty regarding their diagnosis after other tests are performed;
• CCT angiography is considered inappropriate in high-risk patients, routine repeat testing and general screening in patients with no symptoms or other clinical scenarios;
• Calcium scanning is considered appropriate among patients without heart symptoms who have an intermediate risk of heart disease or selected patients with low risk (particularly women or younger men) who have a family history of heart problems;
• Left main stents can be appropriately evaluated with CCT; and
• CCT provides an appropriate option for evaluation of cardiac structure and function in many scenarios.

AUC are intended to help clinicians select the right patients for the right diagnostic tests. Certain diagnostic tests, like CCT, are coming increasingly under fire for adding costs to the health care system and increasing radiation risk for patients. These documents give physicians support for their medical judgment and keep clinical decisions within their purview in the face of these cost and radiation concerns. We hope that by providing broadened and more defined clinical scenarios, these criteria will affect clinical decision making, performance and reimbursement policy.

Take the short quiz below to test your knowledge of CCT appropriateness by clicking the red button. Then, read the 2010 Appropriate Use Criteria for Cardiac Computed Tomography in full on the JACC site.

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Please note that statements or opinions expressed herein reflect the views of the contributor, and do not reflect the official views of the ACCF, unless otherwise noted.

Once is too much, I’m sure, even though I have been lucky enough in my career to escape any malpractice filings. Nonetheless, the AMA has released some interesting data from the 2007-2008 Physician Practice Information (PPI) survey on medical liability. AMA broke down their data from the survey by specialty on four measures of claim frequency:

• The percentage of physicians that have ever been subject to a liability claim in their career to date (“ever sued”);
• The percentage that have been sued two or more times;
• The percentage that have been sued in the last 12 months; and
• The number of claims per 100 physicians (career to date).

The results are not surprising, but eye opening none-the-less. Cardiology has one of the higher rates across the board (49.4% ever sued; 29.8% sued two or more times; 3.3% sued in the last 12 months; 110 claims/100 doctors). Check out the PDF link below for more.

And, be aware that the ACC is working on tort reform legislation, and also is using our new Risk Management Institute to use both educational tools and other ways to reduce risks of suits and costs of coverage for our members. Check out cardiosource.org/RMI for more on this program.

Medical Liability Claim Frequency.pdf (25.81 kb)

Just what so many people feared: comparative effectiveness research (CER) is really a metaphor for comparative payment and -- (dum-da-dum-dum) -- rationing! But, wait a minute. It doesn’t have to result in rationing... what if it was a rational way to create fair payment?

In other words, if the science for CER was considered reliable, evidence-based, and patient-centered (including having a balance of gender, ethnic, and pediatric patients included, for example), then why not pay for interventions and services with better outcomes, and equivalent pay for different services with comparable outcomes?

In the latest edition of Health Affairs, Steven Pearson and Peter Bach propose a novel approach to re-calibrating Medicare payment. Pearson is president of the Institute for Clinical and Economic Review at Massachusetts General Hospital's Institute for Technology Assessment. Bach is an attending physician at Memorial Sloan-Kettering Cancer Center in New York City and a former adviser to the CMS Administrator.

Pearson and Bach note that the Affordable Care Act (ACA) puts strict limits on the ability of the federal government to draw on CER to determine what can be covered under Medicare. But they believe that using well-performed CER to determine how much to pay for newly covered services could yield billions of dollars in savings without threatening patient choice. This really is worth considering. But note that the new PCORI (Patient Centered Outcomes Research Institute), upon which ACC Trustee Harlan Krumholz sits, is precluded from determining payment methodologies.

Under the three-pronged model set forth by Pearson and Bach, Medicare would pay more for interventions that research had demonstrated provided superior results for patients. By the same token, when two interventions demonstrated comparable clinical effectiveness, Medicare would pay the same amount for both. When a new service or treatment lacked any comparative evidence, Medicare would set a tentative payment while research on the intervention's effectiveness was carried out. After three years, if there was no clear evidence that the new service had a clinical advantage over an alternative intervention, Medicare could reevaluate what it would pay for the service.

For new CV interventions (TAVI, Ablation, cell therapy, etc) coverage with evidence development (CED) using registries could accelerate getting data needed for such CER research! We have the registries.

This guest post comes to us from William R. Lewis, M.D, F.A.C.C., chair of the 2010 ACC MDI and chief of clinical cardiology at MetroHealth Medical Center in Cleveland, Ohio.

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As Congress and other policymakers seek to lower costs, improve access and ensure quality in the U.S. health care system, there are increasing opportunities for collaboration between health care providers and payers.

Identifying these opportunities is the goal of the 2010 Medical Directors' Institute (MDI) taking place this week in Washington, D.C. Payment reform, care coordination and the role of payers and providers in quality improvement and cost containment are on the agenda. Conference participants will discuss how various payment models can establish care management processes, improve quality and fairly distribute cost savings and decision making.

MDI participants will also hear from health plans like Horizon Blue Cross and Blue Shield on ways they are working to coordinate care, share patient data and assign performance metrics across sites of service. There will be opportunities to discuss the role of specialists in achieving targets and outcomes, and the ways cost savings can be distributed to participants. In addition, patient centric models such as shared decision making and care management will be explored.

Over the years, the MDI has become a place where cutting edge, evolving issues, such as performance assessment, registry participation and efficiency, are explored and seeds of collaboration are planted. As the U.S. moves forward with implementing health care reform, collaboration between health professionals and health plans is key to ensuring the most effective implementation and the greatest value and support for cardiovascular professionals and their patients. The ACC's MDI is proof positive that such collaboration is not only possible, but key to shaping the future of health care.

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 Please note that statements or opinions expressed herein reflect the views of the contributor, and do not reflect the official views of the ACCF, unless otherwise noted.

I was a speaker last week in another roundtable on “innovation,” something our nation is trashing as we pursue perfection in patient safety. If we want to assure that no patient will ever be harmed by a new therapy or procedure, none will be approved. 

Health Affairs and the National Dialogue on Healthcare Innovation (NDHI) sponsored this meeting. It was disturbing. We are pushing all the research and new product introduction off shore. Nobody seems to know how to stop it. The media is focused on hysterical reactions to predictable side effects. Patients who want the latest care need to be wealthy enough to go abroad to get it. Where is the balance? Why not give patients full disclosure on the uncertainties of new technology and therapy, while allowing voluntary use if coverage is associated with required evidence-development and strict data tracking?

Meanwhile, under media duress, some academic deans there (like Phil Pizzo of Stanford) have banned all faculty from accepting industry funding other than Stanford “approved” research -- no faculty can have accepted any speakers or honoraria, nor can any program be subsidized by industry. There is some virtue in this, no doubt, but this philosophy implies that there can be no ethical partnerships between industry and physicians, relationships with industry are inherently evil. This is wrong. Stanford’s faculty and students will suffer and be less informed as a result. Greater attention to and vigilance regarding stringent transparency of conflicts is a better course.

In one of the first rounds of challenges to the new Affordable Care Act (ACA) health reform law, a federal judge in Michigan upheld its constitutionality. US District Court Judge George Steeh rejected the request for an injunction to block implementation of the individual mandate for health insurance. The decision found that it is within the power of Congress under the Constitution to collect penalties for individuals not obtaining health coverage and require people to buy insurance, under the Commerce Clause.

The court's decision appears to have been based on a finding that the health care market is unlike any other markets because no one can guarantee their health or ensure they will never get sick or require health care services. The court’s analysis suggests that the individual mandate is justified because the risk exists that health care costs for individuals not obtaining health coverage would be shifted to others. Whether you like the law or not, this is a fact of life -- everybody needs to pay their fair share of health costs and not shift the burden to others when they need care.

There are suits filed in 17 states, so this is not the end of the issue, but it definitely helps keep the momentum moving.  Republicans in many states are running on repealing the ACA, but this is truly political hype unless and until there are 60 Republicans in the Senate, and a Republican President. Even then, once 35 million additional people get coverage by 2014, it will be very hard to reverse the law. Opponents to Medicare and Medicaid couldn’t turn those laws around either.

Jack Lewin’s blog post this week summarizes the current situation better than I could ever hope to do, but I want to reiterate that members of Congress are back in their home districts, and are listening to constituents with the acuity that comes at the time of a critical election. They need to hear from all of us about the challenges we face in providing access to quality care for our patients in the face of declining reimbursement from Medicare.

The results of the ACC’s practice census clearly show that practices are cutting staff, postponing or cancelling investments in equipment and curtailing services to Medicare beneficiaries in response to the cuts. Failure to fix the SGR will only accelerate the process. The creation of the Independent Payment Advisory Board provides additional uncertainty, and the concern that poorly thought-out payment cuts will paralyze our practices’ ability to serve our patients has never been greater.

Make sure your members of Congress hear your concerns. Learn more ways to get involved in advocacy on CardioSource.

Check your mailbox for the September/October issue of Cardiology magazine. Some of the highlights:

• Results of an ACC survey of 2,400 U.S. cardiovascular practices
• Head-to-Head Commentary: “Is Fee-for-Service Dead?” by ACC CEO Jack Lewin, MD, and “What is the Future of Private Practice Cardiology?” by Gregory Thomas, MD, FACC, former president of ASNC
• Frederick Masoudi, M.D., M.S.P.H., F.A.C.C., on the lack of clarity on the connection between ARBs and cancer risk
• Results of new study that could disprove FDA’s clopidogrel warning
• Transforming STEMI care through medical simulation by Pat Lucken, F.N.P.-C., C.P.H.Q.

Also, new this issue: a Cardiology Discussions forum on CardioSource.org. Leave your thoughts on some of the issue’s hottest topics in this forum on CardioSource Communities.