This just in…FDA has ordered enrollment in the TIDE trial to stop even though the FDA panel voted last week to continue the trial (the panel did not vote on whether to halt enrollment).

MedPage Today has more on the announcement.

This post was authored by former ACC President Alfred Bove, M.D., Ph.D., M.A.C.C. For more blogging from Dr. Bove, visit his blog on CardioSource Communities, which discusses the Heart and Diving.

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As I listen with my stethoscope to the chest of a patient with the Heartmate II® left ventricular assist device (LVAD), I am struck by the absence of the mechanical sounds so familiar with the prior Heartmate I® device that was a pulsatile LVAD.  Instead, there is a soft whine of the high speed rotor of the axial pump that had its origin in the fuel injectors of the rocket engines used for space flight.

The news about former Vice President Dick Cheney receiving a Heartmate II axial LVAD has raised awareness of the fact that there are now hundreds of patients who are alive, waiting for a heart transplant or living with the VAD as a permanent heart assist device.  These devices have added an important tool to our therapy of end stage heart failure.  When we used chronic inotrope infusion to keep patients stable while they waited for a heart transplant, we found a number of patient who ultimately could not maintain their cardiac output, and required an assist device that was usually an intraaortic balloon pump prior to about 1994.  

Since then we have been able to support the end stage failing heart with an assist device that is well tolerated in most patients and has been shown to extend life in these patients.  With the new design that shifted the pumping mechanism from a cyclic pump that would wear out in 12-16 months, to an axial rotating pump with specially designed bearings that last many years, longer term use of the devices became possible. There are patients in the U.S. who are living for more than 3 years with the devices.  Many return to full activity, and seem to tolerate the device quite well.  We have heart patients that ask about avoiding transplant and keeping the VAD to eliminate the need for the complex medication program and the complications of immunosuppression that occur post heart transplantation.

There are still the complications of infection, embolism, and mechanical failure that are not avoided with the new axial VADS, and the activation of Von Willebrand factor due to the high shear rate of the rotating pump.  The patients also need to be on warfarin anticoagulation.  In spite of the side effects and the care needed to avoid infection, maintain charged batteries, perform VAD failure drills, and the constant questions about what is whirring inside their chest, patients appreciate the fact that they can return to a more normal life without heart failure.  Given his circumstances, I believe Mr. Cheney made a good choice for his heart failure therapy.

Quality in the outpatient setting seems to be a topic that is getting more and more attention in the specialty arena. Some of my primary care colleagues have been looking at their quality of outpatient care for several years now.

If the recent New York Times article is any indication, it seems to me that the insurers will steer patients to physicians and practices that can demonstrate their quality.  The article discusses the increasing demand for health plans that limit patient options for providers to save on costs. The article states:

One way insurers say they hope to prevent ... consumer backlash is by emphasizing that they are not choosing doctors on price alone. The insurers say they look to see how quickly a doctor’s patients recover from surgery, for example. But how much the insurers emphasize quality remains to be seen.

The problem (or, more accurately, ONE OF the problems) with this is that frequently physicians get assigned “quality” by measures that are not created by doctors, or maybe were created by doctors but use claims data rather than clinical data.

If we’re going to get measured, then we need to be the ones creating the measurement system. That’s why the ACC put together something called the Cardiovascular Practice Recognition Program (CVRP), which is practice-level assessment and recognition program designed specifically to identify quality in cardiovascular practice. The CVRP will establish legitimate goals and targets for cardiovascular specialists and their practices. I think this is a program that holds great promise for quantifying quality in the outpatient arena, and we’re working to refine the program even further. You can learn more about the pilot program on CardioSource.

A Washington Examiner editorial last week looked at the special influence that trial lawyers have on President Obama. According to the editorial, the president may grant trial lawyers a $1.6 billion special interest tax break without congressional approval. The tax break would allow plaintiffs’ attorneys to deduct litigation costs the same year they file contingency lawsuits. Typicially, these deductions have only been allowed if and when a case is lost. According to the editorial:

“It is unconscionable that ‘spread-the-wealth’ Obama should force taxpaying plumbers, waiters and bus drivers across America to shoulder up to 40 percent of the cost of wealthy trial lawyers’ litigation with this tax break. Worse, the tax break provides an effective reduction in lawsuit expenses, freeing up lawyers to file more suits that have less probability of success.”

Physicians and medical professionals see first-hand the overwhelming influence that trial lawyers can have over politicians in the back-and-forth struggle to pass tort reform. There are proven strategies that work to reduce the burden that unnecessary malpractice suits have on the legal and medical systems, but we are unable to implement them because of politics. Of course, the lawyers invest more in their PACs than we do, folks! If we were a bit more willing to defend ourselves, we could prevent this $1.6 billion tax break, which arguably would be better spent on health care.

And get this: About nine in 10 physicians said doctors order more tests and procedures than patients need so they can protect themselves against lawsuits, according to a study in the June 28 Archives of Internal Medicine. A story by American Medical News examines the study, which noted that the cost of defensive medicine is estimated to be $60 billion annually. What a waste. Let’s get some tort reform in a cleanup bill in 2011. The ACC is building a coalition to do just that!

This post is authored by ACC Health IT Committee Vice-Chair James Tcheng, M.D., F.A.C.C., and Committee member Jeffrey Westcott, M.D., F.A.C.C.

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Earlier this week, CMS completed a crucial step toward the goal of universal use of electronic health records (EHR) by all practitioners for all patients across the nation. The event?  CMS released its final rule that defines how eligible providers and hospitals can successfully participate in its EHR Incentive Program. This program provides payments – up to $44,000 over five years under Medicare and $63,750 under Medicaid – to providers who can meet its requirements of being a “meaningful user” of a certified EHR system.

According to the final rule, to be a “meaningful user,” you will need to use a certified EHR system and satisfy a series of measures, including 15 core requirements and five out of 10 optional requirements (for a list of these requirements, read this perspective piece by David Blumenthal, M.D., M.P.P., director of the Office of the National Coordinator, or ONC). These include a key core requirement – quality reporting – that builds on the remarkable achievements of the past several decades of the cardiovascular community in improving outcomes of our cardiovascular patients.

The Proposed vs. the Final Rule
CMS received nearly 2,000 comments on its initial “notice of proposed rulemaking” for the program, including extensive feedback authored by the ACC on your behalf.  We were deeply concerned about how CMS proposed to define meaningful use, as the first version included difficult and complex requirements that would have made it virtually impossible for you to participate in the program.

CMS and ONC have clearly been listening. They made extensive changes to the proposed rule in the final rule. For example, in the proposed rule, physicians would have had to meet 25 very specific requirements in their entirety to qualify for the program. This was changed to 15 “core set” requirements, plus your choice of five out of 10 “menu set” optional requirements.

And the metrics for achieving compliance with most of the requirements have been scaled back.  A prime example is computerized physician order entry (CPOE). The initial proposal would have required physicians to use CPOE for 80% of all orders.  Although the Final Rule requires a CPOE system that is able to capture orders for medication prescriptions, laboratory, and radiology / imaging studies, the performance measure for Stage 1 is only that physicians will have used CPOE to author 30 percent or more of medication prescriptions – a significantly reduced requirement.

Additional flexibility has also been added with respect to clinical quality measurement. Rather than requiring practitioners to report on three core measures and a rigid, pre-defined set of 3-5 specialty measures, the Final Rule requires reporting on a total of six measures – a combination of three core measures AND any three additional measures of the providers choosing. There are even alternative core measures that can be substituted for the base core measures.

CMS and ONC did remove several requirements (primarily administrative transactions) from the list of requirements. The proposed rule required professionals to submit claims electronically, as well as to perform the HIPAA eligibility transaction. The ACC and other professional associations successfully argued that these requirements were inappropriate at this time, especially with respect to the HIPAA eligibility transaction, which most health plans, including Medicare, have not fully implemented at this time.

The large number of changes reflects that they listened to the feedback they received. Their changes will help make the program goals – improved quality and patient care – attainable to a larger number of physicians. More...

An FDA advisory panel yesterday voted 20-12 to keep rosiglitazone (Avandia) on the market. The panel vote came after two days of intensive data review. Of the 20 members who voted not to remove the drug, the overwhelming majority recommended the drug include stricter labeling. Half of those votes suggested that rosiglitazone be restricted to prescription only by physicians with special knowledge in use of the drug. Some panelists also indicated that additional patient education is needed. Only three of the panelists voted to keep rosiglitazone on the market without additional product labeling. The 12 members recommending removal of rosiglitazone argued that pioglitazone works just as well without the added risks of ischemic events. 

The panel was also tasked with making recommendations in eight additional areas, including safety of rosiglitazone as compared to pioglitazone and other hypoglycemic drugs. In evaluating whether rosiglitazone presents greater risk compared to non-thiazolidinedione (TZD) diabetes drugs and pioglitazone, the panel voted 18-6 in favor of the notion that sufficient evidence exists to support an increased risk of ischemic cardiac events as compared to non-TZDs. Nine voting members were unable to make a decision on this specific point. The panel also voted 21-4 when asked to determine whether rosiglitazone is less safe than pioglitazone. Eight panel members were unable to decide.

In addition to voting on whether or not the drug should remain on the market and specific safety concerns relative to comparable drugs, the panel was charged with recommending whether or not TIDE, the ongoing international trial designed to compare rosiglitazone to pioglitazone with respect to risk of MI, should continue. In a 20-10 vote, the panel recommended that TIDE carry on (one panelist did not vote and another two were no longer present).

Though the FDA panelists failed to reach a unanimous consensus on any of the nine recommendations, they agreed the available data are confusing and additional information is needed. They also seemed to agree that many flaws exist in the data.

The FDA is expected to make a final decision on the fate of rosiglitazone in the coming weeks. Though the agency is not obligated to follow the recommendations of its panel, it often does. Stay tuned for updates as we learn more.

Mainstream Coverage:

• Washington Post
• USA Today
• Los Angeles Times
• Wall Street Journal 

UPDATE (7/19): Check out the coverage the ACC received in the WSJ's Health Blog, which talks about the difficulty doctors will face making recommendations about the drug to patients.

An FDA panel just moments ago voted on whether diabetes drug Avandia increases the risk of heart attack, stroke and death. By a majority, the panel voted that there is SUFFICIENT evidence to indicate that Avandia, compared to its competitor Actos and other oral hypoglycemic drugs, does increase the risk of heart attack and stroke. However, there is INSUFFICIENT evidence that the drug causes an increased risk of death.

Today's vote is just one of nine recommendations the panel must issue, including whether the drug should remain on the market, be removed or have a stronger warning. It also will determine whether an international trial that compared Avandia and Actos should continue. (See our discussion of a Boston Globe article from late last month on the topic).

The ACC appreciates the deliberation and comments regarding Avandia from the FDA panelists today. The safety and well being of patients is of the utmost importance to the ACC and our members and the panelists today expressed reasons for concern in respect to the drug's safety.

By the panelists' comments, it is also clear more research and independent study would be helpful to fully understand and know the risks associated with this drug. Patients should speak with their physicians about all treatment options available.

This post comes to us from Jeffrey Anderson, M.D., F.A.C.C., chair-elect of the ACC/American Heart Association Task Force on Practice Guidelines and Vice Chair of the 2010 UA/NSTEMI Focused Update. Dr. Anderson also is the Associate Chief of Cardiology at Intermountain Medical Center in Murray, UT.

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Angiotensin-receptor blocker (ARB) agents drugs have shown substantial reductions in the risk of cardiovascular mortality, myocardial infarction and stroke in patients with hypertension and heart disease. However, a recent article in Lancet Oncology that looks at a pooled analysis of studies focused on the cardiovascular effects of ARBS, suggests these drugs may modestly increase the risk of a new cancer diagnosis. It should be noted that the absolute risk is small, the study is retrospective and exploratory, and that the question of class effect versus specific drug effect for the potential cancer risk is uncertain.

The article, while not definitive, has generated a good deal of discussion within the cardiovascular community about how best to react in terms of both further study and in discussing with patients.

As with any product used in the care of patients with cardiovascular disease, the ACC is a huge proponent of understanding both the product’s effectiveness and safety. In this particular case, the College is supportive of efforts to further clarify the association of ARBs and cancer and put the study’s potential findings into better perspective. For example, do the proven benefits of ARBs outweigh the risk of cancer? That being said, these new data should not warrant overreaction.

In the interim, patients should not stop taking ARBs based upon these data, but should work with their care providers to determine the best medication regimen. (If you're looking for a good article to give your patients on the topic, see this CardioSmart article.) The study does not diminish the importance of treating hypertension or left ventricular systolic dysfunction with effective regiments prescribed by their physicians, which may include the use of ARBs. Current UA/NSTEMI and STEMI guidelines, as well as performance measures for heart failure at AMI, remain current in that they generally support ACE inhibitors as first-line therapy where appropriate. ARBs are recommended for patients who cannot tolerate ACE inhibitors. 

What do you think?

- Jeffrey Anderson, M.D., F.A.C.C.

The New York Times Magazine recently featured an interesting article that looked at clinical decision making from a patient/caregiver perspective. “What Broke My Father's Heart” highlights what the author feels was a device that kept her demented father alive beyond what he or the family wished for. If you haven’t read it, I recommend it. We may agree or disagree with the author, but the perspective of our patients and their families is a view we should appreciate. I suspect we have all dealt with situations like this.

Have you had a similar situation? How have you handled it?

Recently, Jack wrote about his views on radiation risks and the need to balance concerns about radiation dose with getting a test done that could reverse a life-threatening condition. Yesterday, a study came out in JACC that finds that cardiac imaging procedures increased risk of radiation exposure and effective doses for those in the study.

Of the 952,420 patients in the study, which were nonelderly adults with continuous enrollment in United HealthCare, 9.5% underwent at least one cardiac imaging procedure associated with radiation exposure over the three years of the study. The mean cumulative effective dose for these patients was 23.1 mSv, with a median dose of 15.6 mSv.

However, as the authors note in their discussion:

“The public health and clinical implications of radiation exposure from cardiac imaging are not easily determined. Clinicians and patients must consider tradeoffs between the benefits of cardiac imaging procedures and their potential long-term risks due to radiation.”

They also note that while “radiation exposure from cardiac imaging procedures may be worth the risk for many patients,” many of the younger patients in the study “may be candidates for alternative imaging modalities that do not use ionizing radiation but provide similar clinical information for informed decision making.”

Editorial Comment
Accompanying the JACC article is an editorial comment that questions the assumptions of the study. The authors write:

“...[T]he entire premise that radiation doses from medical testing causes cancers remains hypothetical. ... [T]he relationship between low-dose medical imaging and harm has never been established.”

They conclude: “We need to move beyond radiation models, with so many assumptions, to studies documenting the real risk (if any) to the cardiac patient.”

My Thoughts
Each of the articles raises important points. On the one hand, patients are being exposed to long-term risks associated with radiation. On the other, we’re not really sure how much of a problem these risks are. Clearly, more research is needed to understand radiation risks in patients: how much radiation puts them at increased cancer risk; how much is the increased risk; and are the tests being performed appropriate.

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 dose include using AUC to eliminate unnecessary scanning procedures; following the principle of “as low as reasonably appropriate” (ALARA) with respect to radiation levels; displaying dose information wherever studies are done; and encouraging facilities to monitor delivered doses and compare them with benchmarks.

Through these efforts, and by working with the American College of Radiology (ACR) and other specialties, we can ensure that patients are receiving the most appropriate and safe treatment possible.

Patient Involvement
Meanwhile, patients need to become more involved in their care, in particular understanding the risks of undergoing imaging and weighing their imaging options. The more patients are able and willing to be involved, the more they are able to weigh the risks and benefits. The ACC currently has its patient education portal, CardioSmart, to assist providers with educating patients about their different imaging options. We hope to include more about radiation risks in the future.

Ultimately, the idea is for physicians and patients to work together to determine the appropriate treatment or test. Such decisions would include a discussion of radiation-related concerns as compared to the risks and benefits of the different diagnosis or treatment options and could lead to better patient understanding of potential side effects.

For more about ACC’s commitment to patient safety in medical imaging, read ACC’s patient safety briefing on CardioSource.

Your turn: Do you think that imaging procedures put patients at undue risk? What’s the best way to mitigate these risks?

UPDATE (7/9): Two mainstream news articles covered the article:

• CNBC
• Sunjay Gupta's blog on CNN
  

I met with two different (unnamed) insurance executives last week who report feeling very, very worried indeed about their uncertain future (I know, a lot of you are getting your hankies out). But, remember recently when California insurance premiums for Wellpoint were going to go up by over 25% according to WellPoint, and everybody freaked out?

Well, the reality is insurance premiums are still going up pretty fast all over the country. Increases of 10-15% are likely to represent “good news.” In the individual and small business the 25% prediction was probably accurate. Liberal Dems will use this information and try and re-kindle interest in Medicare-for-all or at least a public option.

Embattled health insurer Anthem/Wellpoint is reviving its plan to raise rates for tens of thousands of California policyholders, some of whom could see their premiums rise as much as 20%, the Los Angeles Times reports. I think they really need to do this because of higher costs in the individual market. The insurers firmly believe that many small and middle sized businesses will watch premiums increase and then dump their employees into the insurance exchanges at the first opportunity, and the big for-profit health plans therefore think their future business will be limited to large employers, and/or to government contracts through private sector versions of Medicare and Medicaid like Medicare Advantage (MA). Of course, since MA is being hit up for $135 billion of cuts to help fund the health reform law (PPACA) MA plans will be scrambling for cost savings, and may be threatened..

Americans who have been denied coverage by an insurer because of a pre-existing health condition can now finally apply for insurance through high-risk insurance pools," the Wall Street Journal (subscription) reports. Will insurers help to make these pools succeed? Insurance rates should be easier to stabilize if high risk patients are in federal pools, but plans expect big rate hikes this year across the board.

You would think these trends would serve as a wake-up call for insurers to work with physicians realign payment incentives, and start reforming the system to ferret out waste and improve quality. I hope that happens, but thus far I’m seeing more ringing of hands and girding of loins than innovative action. Private insurers still don’t seem to get it. I’m hopeful they will (naïve).

Incidentally, if the insurers worried about premium increases and government regulation, the big employers are just as concerned. The Business Roundtable estimates the average insurance premium for an employee (plus dependents) in 2019 is likely to be well over $25,000 (oops), and that employer health care spending will at least double in this decade. In fact, employee salaries will be in bad shape (flat?) if health benefits don’t come under more control. Employers believe the solutions to these issues have to include:

• Individual accountability – meaning no “free riders” in the marketplace, and individuals need to come up with a larger share of health premium costs and to adopt some healthier behaviors
• Full transparency and public reporting of cost and quality information
• Reducing variation in practice patterns
• A real focus on health, not illness
• More investment in health IT adoption
• Supporting physicians to move to paying for value rather than volume, promoting quality and wellness, and working with patients in shared decision making toward reducing unnecessary things.

We’re on the same page. I think. I hope. Change needs to happen or we’re all in big trouble.

President Obama last week signed into law a bill (H.R. 3962) that gives a six-month patch to the sustainable growth rate (SGR) formula with a 2.2 percent payment update through November. This update replaces the 21 percent cut that went into effect June 1, and will be applied retroactively to claims for services paid under this cut.

Although this is obviously in some part a good thing, one thing we need to continue to remind our elected representatives is that just as tar balls on the beach are affecting the lives of millions of “small people,” the Senate/House shenanigans that we’ve witness getting to this point jeopardize the access to care for millions of “small voters” and threaten the practice of our specialty.

We need to call our elected officials and tell them to stop acting irresponsibly and pass a bill that either creates a new payment system that encourages high quality care or – at the very least – includes a longer-term fix so we don’t have to fight the same battle over and over again. We need to encourage our colleagues to call, too. The Hill visits this September for our Legislative Conference are not shaping up to be happy ones but clearly the need to educate Congress about the impacts of the cuts is strong. If you haven’t registered for the Legislative Conference, now is the time to do so.

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.