The ACC has an excellent survey team (better -- seriously -- than Gallup polls). The team has a cohort of about 400 cardiologists of all subspecialties, ethnicity, gender, and practice types who have agreed to respond quickly and regularly to mini-survey instruments. We call this group and process CardioSurve.

The June CardioSurve panel questions on preferred and predicted future reimbursement mechanisms revealed that, essentially, depending upon which side of the practice fence you sit (i.e.: Private Practices vs. Non-Private Practices) greatly determines your current compensation source and your ideal compensation source.

Nearly two-thirds (63%) of cardiologists in private practices are currently compensated on a fee-for-service basis (FFS) exclusively; and, similarly, nearly two-thirds (65%) of these private practice cardiologists indicate that their ideal compensation is fee-for-service. Some of this response seems to be related to fear that doctors are due to be shafted regardless of what form of reimbursement is used. Therefore stick with the devil you know -- even if it is constantly declining.

Conversely, more than three-fourths (78%) of the cardiologists who are not in private practice currently receive a salary as their primary source of income.  However, interesting to note is that only 57% of these cardiologists state that a salary is their ideal form of compensation.  Fee-for-service (19%) and a mixed compensation system (22%) actually gain strength among them for ideal compensation. This makes sense. Salaried cardiologists deserve incentives for productivity (everybody doesn’t work as hard) and quality (everybody doesn’t strive as effectively for better outcomes). Incentives have to be based on relevant data comparisons—not conjecture. That’s why the PINNACLE Registry, which can measure individual outputs and performance related to evidenced based care, is so critical.

The ACC Foundation and the American Heart Association yesterday released a joint clinical alert on clopidogrel (Plavix). The alert is intended to help CV professionals make sense of a recent FDA black box warning for the drug saying that some patients’ genetic makeup can affect their response and put them at risk for serious adverse events.

Two to 14 percent of patients are “poor metabolizers” of clopidogrel and do not benefit fully from it, according to FDA analysis. Information about the specific genetic variation that might affect clopidogrel metabolism – and thus, lead to suboptimal clinical responses – is increasing, but there still isn’t sufficient evidence available to develop specific recommendations related to genetic testing in patients. Many questions remain about how and when to use genetic tests for clopidogrel candidates, which tests to use, as well as whether tests will be reimbursed.

The new ACCF/AHA report reviews the backdrop for the black box warning, including the multiple unknown factors that can influence individual patient outcomes. Its recommendations for practice are as follows:

1. Adherence to existing evidence-based guidelines from ACC, AHA or other professional societies for using antiplatelet therapies should remain the foundation of care. If clopidogrel is prescribed, health care providers should help ensure that patients take it as prescribed.
   
   
2. Clinicians must be aware that in certain patients with either acute or chronic coronary artery disease, genetic variability in response to clopidogrel can affect its inhibition of platelet function.
   
   
3. Careful clinical judgment, including weighing the risks and benefits, is needed in considering all therapies. The new boxed warning points out that for clopidogrel, if there is a lack of efficacy, the consequences can potentially result in fatal outcomes.
   
   
4. Results from ongoing clinical trials in large groups of patients will provide more information about the predictive value of genetic testing and better inform the role genotyping might play in personalizing medicine and optimizing outcomes.
   
   
5. Genetic testing to determine if a patient is a “poor metabolizer” may be considered before starting clopidogrel therapy in patients believed to be at moderate or high risk for poor outcomes (e.g., patients undergoing elective high-risk PCI procedures).
   
   
6. Using alternative antiplatelet therapies or altering the dosing of clopidogrel may be reasonable options in patients who experience an adverse event while taking clopidogrel and have been taking the drug as prescribed.

These recommendations are intended to help guide health care providers in devising the best treatment plan for each patient. That said, care providers of course should continue to use careful clinical judgment in each patient.

Relationships With Industry

An interesting side note to this document is that it was the first major clinical document to be produced under a new set of ACC principles for relationships with industry for the development of clinical documents.  Of the many things discussed in the document, one principle outlined is that the chair of the writing committee and greater than 50% of its members must have no relevant relationships with industry.

For the clopidogrel document, only two out of the five authors have relevant relationships with industry that needed to be disclosed.  ACC Vice President and writing committee Chair David Holmes, M.D., F.A.C.C., did not. Being 2/3 of the way free of relationship represents a vast improvement over both our previous clinical documents and our new RWI guidelines. It’s important to the ACC that it be able to offer unbiased clinical documents. It’s not that we think that cardiologists who accept money from drug companies are biased  (we believe that the RWI can provide value when such relationships are ethically structured) , it’s just that we feel strongly in the importance of transparency and maintaining rigorous levels of relationship-free writing committee members helps us to do this.

I’ll be talking more about relationships with industry in the coming weeks, but I’m interested to hear what you think now. Should clinical document writing committees exclude physicians because they accept industry funding or is there an acceptable level of relationships within a writing committee?

UPDATE (7/1): Watch a CVN video with writing committee chair and ACC Vice President David Holmes, M.D., F.A.C.C., explaining the alert.

We’re still fiercely fighting the 2010 Medicare Physician Fee Schedule (Payment Rule), and the new one has been issued in draft. The comment period runs through the summer, with the final Rule due out in November.

Let me summarize by saying it is what we expected. No new significant cuts, but no reversal of last year. We weighed in early on the Stark issue and CMS has taken our recommendation to limit application of the new disclosure requirement to the imaging modalities specified in Affordable Care Act even though there was discretion to expand to all imaging. There are some elements of how CMS is proposing to implement this that we will want to try to get changed, but limiting the scope of it is a big win.

We're still reeling from the unintended but horrific consequences of last year’s Rule -- it killed off more than 50% of the private practice of cardiology in the US. Done. Gone. Not likely ever to return from hospital employment. And the remaining practices are not doing well.

See the all-member alert for the specifics of the 2011 Rule.

The Associated Press featured an article earlier last week about the safety risks in radiation. According to the article:

“Americans get the most medical radiation in the world, even more than folks in other rich countries. The U.S. accounts for half of the most advanced procedures that use radiation, and the average American's dose has grown six-fold over the last couple of decades.”

The article notes the different reasons for the use of testing (accuracy, malpractice, patient pressure, etc.) and notes that children and young women – not the type of individuals usually treated by cardiovascular professionals – are the ones most at risk for radiation. The article urges patients to question their doctors about the radiation dose their receiving and whether the test is necessary.

Radiation exposure is an issue of concern to us. But cardiac disease continues to be the number one cause of morbidity and mortality. Radiation exposure cancer is way, way, way down the list.

While the ACC agrees that patients should be aware of how much radiation dose they receive, there needs to be a balance to concerns about radiation dose and getting the test done that could reverse a life-threatening condition. We’ve had a 30% reduction in CV morbidity and mortality over 10 years -- millions of people are alive because they pursued the right interventions. We can’t afford to apologize for making this kind of statistically significant difference.

But, neither can we be apologists for radiation exposure for test that don’t need to be done. That’s what AUC (appropriate use criteria) are all about. When will insurers and Medicare figure out how to help us get better information about AUC applied at the point of care. Most inappropriate images are ordered by non-cardiologists who mean well, but couldn’t be expected to keep up with the breath taking progress in imaging and CV science.

That said, radiation exposure really can be problematic. My advice to radiology: wear those lead aprons, folks.

The Boston Globe published an interesting article this morning on a clinical trial underway for diabetes drug Avandia. Seventeen physicians are in the process of recruiting patients for a trial that would look at the increased risk of heart attack that has been reported to be associated with the drug. According to the article:

Many specialists — including some officials within the FDA — contend that the drug is too dangerous to remain on the market and that the ongoing Avandia clinical trial is unethical, exposing patients to needless risk of cardiovascular harm.

But the drug has its defenders ... who say it has not been proven to be harmful. The clinical trial, they say, promises to provide answers about the drug, which has been on the market for more than a decade and last year was prescribed more than 2 million times in the United States.

As the Globe article notes, the controversy over Avandia “demonstrates how ... the FDA is still struggling to find the correct response when evidence emerges that big-selling drugs are unsafe.”

What do you think? Should the FDA continue with the trial?

Compliance for 24 performance measures for coronary artery disease, heart failure and atrial fibrillation ranges from dismal to nearly perfect, according to a new study in JACC using data from the PINNACLE Registry™, ACC’s outpatient registry.

The study, by Paul Chan, M.D., F.A.C.C., and others, found that compliance on ACC/AHA/PCPI performance measures in the three areas ranged as low as 13.3% (for CAD patients screened for diabetes mellitus) to as high as 96.7% (for heart failure patients with blood pressure assessment). The study looked at data from 27 practices and 14,464 patients, for a total of 18,021 clinical visits, enrolled in the PINNACLE Registry between July 2008 and June 2009.

Clearly, these results are mixed. While the nearly 100% adherence to some of the performance measures is fantastic, the lower adherence levels show areas where improvement is necessary. The authors take a “half-glass full” approach to the results:

... [W]hile rates were suboptimal for a number of performance measures, these results identify opportunities for future improvement and provide a valuable benchmark with which progress can be measured.

In addition, the authors note that there were “no substantial racial or sex differences in compliance rates for key performance measures for” CAD, HF and AF.

The PINNACLE Registry, the first outpatient registry to successfully measure performance in the cardiovascular setting, was created for studies like this one. Because we’ve never attempted to measure the quality of care provided in the outpatient setting, we have no idea how good, bad or variable it is. While we might not be completely encouraged by the findings of the study, at least now we know the areas we need to work on.

Challenges Ahead
In an accompanying editorial in JACC, Sunil Rao, M.D., F.A.C.C., admonishes: “The PINNACLE program serves as a reminder that clinical care does not occur in snapshots; it is longitudinal, interrelated, and spans across specialties and diagnoses.”

Challenges exist not only in ensuring the high-quality longitudinal application of evidence-based care but also for the seamless development of PINNACLE to enhance ease of use to assess and improve quality of care. This ambitious effort of the ACC involves the harnessing of the power of IT and informatics so that all electronic medical record vendors are “cross-platform compatible” to have work flow data entry following clinical processes and ensuring data is “auto-populated” so there is no human duplicate data entry across different systems.

The future vision of PINNACLE includes embedding decision support tools using ACC’s appropriate use criteria so that we will be able to not only ensure quality of care but enhance appropriateness in minimizing needless and non-productive testing. This will be necessary to truly “bend the cost curve of health care.”

For more information about PINNACLE or to enroll your practice, visit: https://www.pinnacleregistry.org. 

The past several weeks have been frustrating for any physician in the United States, and perhaps even worse for cardiologists trying to run small businesses. Congressional gridlock is at its best as the debate over the sustainable growth rate (SGR) continues. The so-called “patch” keeps getting smaller and smaller and, as of right now, it looks like it will be Groundhog Day all over again come November.

As things currently stand, the Senate last Friday passed a six-month patch that would give doctors a 2.2 percent payment update through November. The agreement is now before the House, which could vote as early as tomorrow.

The ACC’s Legislative Conference in September will definitely be interesting if nothing is done before November to find a longer-term solution. The continued state of limbo is making it difficult for practices already struggling with reduced payments. You can’t plan for the future when the “future” changes every 30 days. To make matters worse, the 2011 Proposed Medicare Physician Fee Schedule is expected out later this month and, while we don’t know all that’s included, we do know the second year of the phased-in practice expense cuts will hit cardiovascular practices. There will also be additional SGR cuts.

I think it will be critical to use our face-to-face time with members of Congress to educate them about the current state of cardiology and what needs to be done in terms of payment reform and health reform implementation. We must also use this time to have a frank discussion about the value of cardiology as a specialty. We come to Congress as an association of cardiovascular professionals. We can proudly point to innovations that have led to meaningful reductions in cardiovascular death and disability. We also remain committed to the appropriate and safe use of imaging, the reduction of readmission rates and the prevention of cardiovascular disease.

In the meantime, it’s important to note that CMS as of June 18 is processing June claims at rates that reflect the 21.3 percent SGR cut. If the House and Senate act to avert the cut, claims will be processed as follows: (1) where the submitted charge is higher than the new rate, the contractor will automatically reprocess the claim; and (2) if the submitted charge is lower than the new rate, the physician should call the contractor. According to the AMA, no one is going to be reviewing the limiting charge for the period that the cut was in place because CMS assumes Congress will ultimately make the fix retroactive.

You will notice something different about The Lewin Report tomorrow – as in its no longer called The Lewin Report. We wanted to make this space more reflective of the wide range of issues cardiovascular professionals are interested in, so beginning tomorrow, we’re adding two more authors and changing the blog’s name to The ACC in Touch blog. (ACC in Touch is the name of our social media campaign. And yes, our Communications staff gets points for creativity!) For now, you can continue to access it through lewinreport.acc.org, but you’ll want to update your bookmarks to blog.cardiosource.org tomorrow and your RSS feed if you have it.

With that said, let’s give a big welcome to our two new authors: ACC President Ralph Brindis, M.D., M.P.H., F.A.C.C., and Board of Governors Chair Richard Kovacs, M.D., F.A.C.C. Ralph’s been involved in the ACC for about 15 years now (talk about commitment), with notable roles such as president of the California Chapter of the ACC and chief medical officer of the NCDR. Dick has been our BOG chair since March. These great leaders are charged with balancing out my tendency to focus on health policy to include discussions on the latest quality and clinical news. So if you haven’t signed up to read this blog as soon as it comes out, this is definitely the time to do so (enter your e-mail address in the box on the right).

Where in the world is ... ACC.org?

As if that wasn’t earth-shattering enough, even BIGGER changes are happening on ACC’s main websites, ACC.org and Cardiosource.com.

If you’ve visited ACC.org recently, you would have noticed an image advertising ACC’s new website, CardioSource.org, which launches tomorrow. CardioSource.org represents ACC’s commitment to ensuring its members have access to all the critical information they need to be the best cardiovascular professionals they can.

If you try and visit ACC.org or cardiosource.com beginning tomorrow, you’ll be redirected to CardioSource.org. CardioSource.org combines the everything you need to know about the ACC – its advocacy efforts, education, membership, practice management, you name it – with all things clinical into one site.

What does this mean for you? It means you’ll just need one site to get access to everything CV that you love. Some of the things you’ll notice –

• It’s customizable. You can choose what page you see when you visit the site, see what products you’ve purchased, and track how much CE/CME you’ve completed and more.
• It’s member-driven. ACC leaders across all areas have come together to provide oversight and direction to ensure that the site represents what our membership wants.
• You create the content. CardioSource.org features CardioSource Communities, a private social network for users of the site. Through CardioSource Communities, you can share knowledge, collaborate and ask questions of your peers.

As much as I’m sure you enjoyed the redundancy of our previous set-up, I KNOW you’ll enjoy new streamlined CardioSource.org. For more on what CardioSource.org has to offer, read this article.

“Medical loss” is the insurance term for health care to patients. Is this comforting to you? In the insurance world, the insurance premium is divided into two parts: “medical loss” and “administration and profits.” The higher the percentage of administration and profits, the lower the percentage of medical loss, and vice versa.

When you go to see your doctor, you should understand that you are a medical loss. Defining what goes into the medical loss ratio (MLR) is one of the most controversial features in the regulatory process of moving the health reform legislation (ACA) forward. That’s because the law sets minimum limits nationally on the MLR for all insurers for the first time. The MLR for the individual and small business market will now be 80 percent, meaning administrative and profit costs cannot exceed 20% of premium; or the companies have to spend 80 percent of your premium dollar on health care. For big business coverage, the MLR will be 85 percent.

The briar patch here is what should be included in the MLR vs. in the ‘administration and profit’ pot. For example, would quality of care measurements, and/or registries, and/or clinical decision support systems be part of the MLR? Or could they be counted in the administration side? Insurance companies say that quality of care systems, disease management and other care management processes have to be included within the MLR, or they will be bankrupted. Some companies want to include the insurance brokers who sell insurance to companies as part of the MLR — that seems wrong. But, quality of care activities — assuming they improve health care or health for patients — should be included as medical loss, I believe.

Insurance companies are worried that if these regs come out negatively for them, that this is a ploy to put them out of business and move toward a single-payer system. I don’t think that’s the intent, but there are some understandable reasons they feel this way. Medicare claims a medical loss ratio of about 96 percent (meaning about 4 percent goes to administrative costs). But Medicare transfers a lot of administrative hassle, paperwork and other details to doctors and patients. Most nonprofit insurance companies would reasonably be expected to have MLRs that exceed Wall Street-owned insurers, and with few exceptions, this is the case.

The ACC thinks that any service or process which improves patient care, prevention, outcomes or chronic disease management is legitimately part of the MLR. But insurance brokers? No way. Incidentally, in some coverage areas the amount of money in the premium dollar that goes to the insurance brokers is more than is paid in aggregate to doctors! Nice.

The House on Friday voted 245 to 171 to pass the tax “extenders” legislation, which includes the SGRrrr physician payment fix, but only for a 19-month period extending through Jan. 1, 2011. So, this week the House went from proposing a 5-year fix, to a three-and-a-half year fix, to a two-and-a-half year fix, to this. The direction is NOT good.

Meanwhile, the Senate just adjourned for recess (meaning, I guess, they’re out on the playground now?). They did not choose to vote on this. They may not the votes for a 6-month solution.

So, a 21 percent cut for all doctors in America is in effect today, after 10 years of flat Medicare reimbursement. The plan in the Senate is to take up the issue again when they return on June 7. However, the Senate doesn’t likely have the votes to approve this $25 billion one-and-a-half year extension, so they will require that the House reduce its proposal again we suspect. 

Anticipated Action
The Department of Health and Human Services (HHS) will be holding payment claims for 10 days in June in anticipation of some action on the part of the Senate. My guess is it will be another one- or two-month extension. Enough really is enough here. This is patently ridiculous, and it will mean more and more people will be unable to afford to take on Medicare patients—a disaster for the health and well being of senior citizens.

Fathom this: Congress has accumulated over the past 10 years an estimated but unrecognized addition to the national debt of $371 billion related to kicking the SGR payment formula cuts down the road instead of correcting the formula, and now they’re adding another $25 billion more to the IOU tab if they were to approve the 19 month arrangement. And, nobody gets anything for this. There is not $25 billion in additional health benefits. We’re just paying off a debt to a flawed formula. What other business sector besides medicine would accept this absurdity?

The ACC was quoted in the National Journal this week urging Congress to get past this nightmare issue so we can begin to work on legitimate payment reform and quality improvement nationally. This is ludicrous. Given that so many Americans have been frightened by speculation about health care costs and threats to their own coverage as a result of the health reform legislation, this just makes things worse. Most seniors across the country already know their doctors are running scared. So, what does expanded coverage and access mean when there will be no doctors available to take care of people? I don’t know about you, but I’m getting a little sick of this.

You can read our official ACC statement. As you can imagine AMA is furious about this as well.