It’s been a while since we’ve heard about the Physician Payments Sunshine Act, (read previous blog posts here and here) but this week the Centers for Medicare & Medicaid Services (CMS) released the long-awaited proposed regulations.  A requirement of the Affordable Care Act, the Sunshine Act requires drug and medical device companies to publicly report their payments to physicians.

CMS had missed their deadline of October 1, but after some pressure and criticism from lawmakers and industry, the agency released the rules just in time for the holidays. Since the rules are late, data collection will not begin until the final regulations are issued.

The ACC has a stringent position on conflicts of interest and relationships with industry, and while we strongly support transparency in physician and physician organization relationships with industry, we believe that it is critical this information be placed into the proper context, and made publicly available in a format understandable by the average consumer.

The College will be submitting comments on these proposed regulations to make sure the Sunshine Act process is as transparent and accurate as possible. View the comments submitted to CMS earlier this year here. For more information, visit www.cardiosource.org/Advocacy.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The U.S. Senate Commerce Committee and the Delaware Insurance Commission last Friday released separate reports on the results of their investigations into consumer access to imaging tests in Delaware. Both reports were commissioned in 2010 after the Wilmington, Del., newspaper ran a story on a Delaware man that was denied a cardiac stress test by MedSolutions, BCBS of Delaware's “radiology benefit manager (RBM).”  The man ultimately was admitted to the ER, and then received CABG. NBC Nightly News ran a story on it yesterday, as did TheHeart.org and Cardiovascular Business.

The report highlights ACC's concerns with RBMs, such as the administrative burdens for doctors and patients, the non-transparent decision-making tools, and the chronic lack of best science and appropriate use criteria in their methodologies. Let's face it, RBMs are designed to save money, not improve care. 

The investigation's significant findings were: 

• After an outside consultant reviewed the denied cases, MedSolutions denied a significant number of both inappropriate and appropriate test requests
• The RBM's pre-authorization process is burdensome and confusing for consumers and health care providers, and this confusion is compounded by conflicting “evidence-based” cardiac testing guidelines
• According to their own professional guidelines, Delaware doctors routinely order unnecessary nuclear stress tests

But, there may be a happy ending here:  The ACC is working to implement the FOCUS imaging appropriate use criteria (AUC) tool in many states that are beginning to express interest in saving money AND improving careas as an alternative to RBMs, and we're making great progress! Yesterday's ACC Advocate has more about the findings and "next steps" of the report. The Senate report is available here: Consumers' Access to Diagnostic Heart Tests in Delaware.

Does this report surprise you? Have you had any similar experiences with RBMs?

A study in JACC yesterday looked at the inclusion of three new attributes to predict in-hospital mortality following PCI that has implications for public reporting of hospital performance. In Massachusetts, where the study was conducted, reporting of in-hospital PCI mortality rates has been required since 2003 through the NCDR CathPCI Registry. However, since the CathPCI Registry was not built for public reporting and not intended to identify high-risk clinical scenarios, physicians in 2006 recommended inclusion of three additional attributes, which they deemed “compassionate use” (CU) measures. These measures are: coma on presentation, active hemodynamic support during PCI and cardiopulmonary resuscitation at PCI initiation. The purpose of the study was to see if including these measures was feasible and would improve the prediction model for in-hospital PCI mortality.

Researchers divided patients into two categories: those presenting with STEMI or cardiogenic shock (which they called the SOS group), and all others (the non-SOS group). The findings were definitive:

• The unadjusted in-hospital mortality rate was 15.6 times higher for CU patients vs. non-CU patients in the SOS group;
• CU patients only represented 1.6% of all SOS patients, but represented 21% of the overall mortality after PCI for the SOS group; and
• Being designated CU was associated with an odds ratio for in-hospital death of 27.3 relative to the non-CU SOS patients, after adjusting for other known predictors of in-hospital mortality.

The authors conclude:

“The Massachusetts experience demonstrates that a small proportion of patients at extremely high risk of in-hospital mortality can be identified using objective, pre-procedure clinical factors that had not been previously collected as part of traditional quality monitoring efforts. Incorporation of these CU covariates in risk-adjustment models led to significant improvements in model performance as well as reclassification of predicted risk in a substantial proportion of cases.”

Editorial
Eric Peterson, MD, MPH, writes the editorial that accompanies the article. He’s right on in his comments. With patients and the government increasingly demanding transparency in health care outcomes, there is a true risk of unintended consequences if we do not do due diligence in taking into account as many predictors of adverse outcomes as necessary. There are plenty of anecdotes of physicians refusing to perform CABG or PCI because they simply don’t want to have a death on their outcomes report by caring for patients whose clinical status is so extreme that their chance of surviving the hospitalization after the emergent CABG or PCI might be less than 30%.

Although the NCDR has a robust risk adjustment model to “level the playing field” to take account of these very ill patients, Resnic, et al., offer CU risk adjustment measures that appear to be an improvement in accurately risk-adjusting the severity of illness for these infrequent but critically ill patients. The use of the CU measures might hope to mitigate against the negative unintended consequences of public reporting – that is to say, physicians would be more willing to take these ill patients to the cath lab for emergent PCI rather than refusing to do so.

The challenge of the CU risk-adjusted measures is for its accurate “coding” by the data analysts when submitting their registry reports. A robust auditing system of all patients deemed to meet CU criteria is necessary to assure accuracy in the coding of these patients.

What do you think of the study findings? Should (and if so, how) CU criteria be incorporated into public reporting efforts?

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.

The ACC has secured representation at a somewhat historic meeting of the regulatory pharma-device agencies of the EU, UK (NICE), and US (FDA) in France on Jan 27-28, 2011. Mitch Krucoff, MD, FACC, of Duke, and Doug Weaver, MD, MACC, of Henry Ford, are our representatives. The idea is to collaborate on these efforts and speed up approvals and innovation of new cardiovascular technological advancements. In addition, its goals are to establish:

• General principles of clinical efficacy and patient safety for the use of diagnostic and therapeutic devices in cardiovascular medicine
  
  
• Recommendations for the clinical evidence (criteria) and systems that should be required by regulatory authorities before granting approval to new devices in cardiovascular medicine
  
  
• Recommendations for the monitoring of the performance of medical devices after they have been granted regulatory approval

A meeting with such an esteemed panel of representatives from these major agencies has never occurred before. Lessons learned from this conference with our European colleagues should be very helpful for the FDA and the U.S. cardiovascular community to become more forward-thinking in the diffusion of innovative CV technology while at the same time not relinquishing our well-known high standards for safety and efficacy evaluations of such. With Dr. Krucoff’s expertise with his leading role in FDA’s Critical Path Initiative and Dr. Weaver’s role as past president of the ACC and chair of the CathPCI NCDR steering committee, we indeed are well represented.

It’s time to compare doctors on quality performance and make it public.  The Affordable Care Act (ACA) requires the Centers for Medicare and Medicaid Services (CMS) to develop a “Physician Compare” website similar to “Hospital Compare” site already in use for hospitals and other facility providers. By 2011, the website will post information on physicians who successfully participate in Medicare’s Physician Quality Reporting System (formerly PQRI). On Wednesday, CMS held a five-hour-long town hall with physicians, hospital representatives, employers and others to figure out what exactly this site should include. HealthLeaders Media reports some of the questions raised include:

• "Will a physicians' charges be part of what's viewed? Or whether they ever make housecalls? Do they enroll patients in clinical trials, accept money from pharmaceutical companies, or spend a good portion of their day in the classroom?
• Can the patients talk with them by e-mail? Do they have an electronic medical record system in their practice? Who covers for them when they go on vacation?
• How many patients must a physician care for in order to qualify for inclusion, so the data has enough power to be right, and over how many months or years?
• Should quality and patient satisfaction measures be included for non-Medicare/Medicaid patients, the privately insured or self-pay patients the doctor may treat? And should those scores be shown separately, so patients can see if the doctor treats all patients the same?
• Should the website show how often the doctor updates his continuing medical education, and in which specialties he's overdue?"

AMA Prez James Rohack, MD, notes in that article their concerns about the site: “We want to have reliable information that a patient can use if they are trying to select a physician or facility to get elective care... But our concern is that individual doctor level data right now is not read[y] for prime time, especially in complex situations. The attribution of who's really responsible for that care is not worked out."

With just 59 days left to get the site together, I predict it will be lame. They need the help of the profession -- us for CV care issues -- to do this right. Good luck and God Bless.

A major provider of diagnostic lab testing, Quest Diagnostics, this week introduced Gazelle, a secure mobile health platform that allows users to receive their lab results and manage their personal health information directly from their BlackBerry, and iPhone, and soon, Android, smartphones.  This a radical empowerment step for patients. They can see their results at the same time as their doctor -- which is potentially unnerving in terms of patient misinterpretation of abnormal results. Quest will not post potentially fatal diagnoses (HIV positivity, path tests positive for cancer, for example) before doctors have a chance to communicate directly with patients, but this is nonetheless a fairly bold move. Many patients will love it.

Gazelle users can see, store and share their vital health information with ease and security anywhere. Patients can forward results from a consultant or specialist doctor (or ER) to their primary physician, or visa versa. The program also offers an optional wallet card instructing Emergency Medical Services (EMS) personnel how to access Gazelle in the event of an emergency.

Gazelle also features a mobile appointment scheduling application that allows patients to either enter their zip code to find a local Quest Diagnostics location, or to use the smartphone's GPS capability, which automatically identifies the patient's current location and displays the next available appointment times at the closest Quest Diagnostics locations.  Pretty cool, folks.

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?