The House on Monday passed a one-month extension of a moratorium to stop the 23% cuts to the SGRrrr (Sustainable Growth Rate physician payment formula with my ‘rrr’ added as an appropriate growl) from going into effect Dec. 1, which the Senate passed earlier this month. That means that Congress only has a few week in December to work on getting at least a year-long extension of the moratorium through Jan. 1, 2012. Woohoo (note the sarcasm).

Their inaction is not surprising. The partisan rancor has been horrible. If the SGRrrr cuts are allowed to go through, I certainly hope people will react this time and not just quit practice or roll over.  This has gotten ridiculous -- actually ludicrous and insulting.

The national news this Thanksgiving weekend was inundated with stories about doctors cutting or reducing their Medicare patient care, as doctors’ offices practice costs often exceed what Medicare pays. The Washington Post cited an AMA study that found that nearly one-third of primary care physicians said they are currently restricting the number of Medicare patients they see. Meanwhile, the Wall Street Journal ran an excoriating story on the AMA and the SGRrrr. WSJ disparagingly cites AMA’s recent support for the ACA health reform bill, in exchange, they say, for cutting a deal with Congress on eliminating the SGRrrr, which Congress then ignored after the bill was passed.

I felt the article badly mistreats the AMA, whom they characterize as fools. AMA wasn’t only focused on the SGR in their advocacy on reform. That was big. But, they have long supported expanding access to care, needed insurance reforms, and promotion of prevention and new payment models, such as could be fostered through CMS Innovation Center grants. Yes, AMA has taken the SGRrrr battle on for all physicians, securing 7 years of delays in implementing the formula’s perennial cuts. But Congress arrogantly double-crossed AMA this year. This SGR debacle is something Congress should be ashamed of, not the AMA.

Congress pretty much thinks doctors will roll over if these cuts go through. I hope that is not the case, but we are dedicated to taking care patients. But, enough is enough here.

Deaths from congenital heart defects in both children and adults have declined over the last 7 years for which complete data is available, according to new research. From 1999 to 2006, we saw a 24% decrease in death rates resulting from congenital heart disease among all ages, says researcher Suzanne Gilboa, PhD, an epidemiologist at the National Center on Birth Defects and Developmental Disabilities at the CDC. Thank you pediatric and adult CHD cardiologists and clinical teams!

ACC’s Gerard Martin, MD, FACC (chair of the Adult Congenital and Pediatric Cardiology Council), was quoted in the article. He said: "It's exciting news for parents who have a child with congenital heart disease and it's exciting news for all the professionals who take care of children with congenital heart disease.”

We’ll be able to track further progress in CHD much better now, given the ACC recently launched the IMPACT Registry, which assesses the prevalence, demographics, management and outcomes of pediatric and adult patients with congenital heart disease who are undergoing diagnostic catheterizations and catheter-based interventions. Not surprisingly, Martin’s Children’s National Medical Center is our first participant! The collection and analysis of the IMPACT Registry’s will provide significant contributions to the knowledge base and outcomes associated with congenital heart disease. Learn more and register: https://www.ncdr.com/IMPACT/default.aspx.

I had the distinct honor of being named the Disruptive Women in Health Care’s November “Man of the Month.” The blog interviewed me on my thoughts on innovation. Here are some highlights:

Q: Can you elaborate on the relationship between innovation and patient safety?

Today’s regulatory agencies in the US have become more conservative than in the EU, UK, and elsewhere in the world....  From the point of view of CMS and the federal government, the focus is so fixed on cost containment that the agencies don’t think about how to jump beyond the problem of rising costs by reducing the need for outdated therapies and diagnostic devices and replacing them with better ones that essentially reduce morbidity and decrease overall costs.... 

Q: What are some promising innovations in the field of cardiology?

Promising innovations include the TAVI percutaneous valve replacements as well as new devices that provide ventricular assistance and support, and new short-term uses for ventricular assist devices.  Cardiovascular genetics and cardiovascular cell therapies are also an expanding frontier.... 

Q: It seems innovation is disruptive; is the disruption it causes positive or negative in your opinion?

The disruption of innovators can be both positive and negative. Anytime there is rapid progress there is the risk that valuable elements of the present can be left behind.  Disruptive innovators challenge the status quo, which is critically important.  The US could be headed towards mediocrity if we choose to drive into the future with our eyes on the review mirror. We need to embrace change and seek a better future through innovation, while making sure we retain what works in the past and present of health care as we speed into the future.

There’s a lot more than is featured here, so make sure to read the full post over at the Disruptive Women in Health Care blog.

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.

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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Bristol-Myers Squibb and Pfizer last Wednesday announced that they have discontinued the Phase 3 APPRAISE-2 clinical trial in patients with recent acute coronary syndrome (ACS) treated with apixaban or placebo in addition to mono or dual antiplatelet therapy. Apixaban is an investigational oral factor Xa inhibitor, a new class of agents being studied for the prevention and treatment of blood clots. The trial, which is one of nine clinical trials evaluating apixaban in patients at risk of ischemic events, was stopped after clear evidence emerged that patients randomized to apixaban saw a significant increase in bleeding, without a “meaningful reductions in ischemic events.”

Apixaban also is in Phase 3 trials as a treatment for prevention of stroke in patients with atrial fibrillation compared with warfarin (the ARISTOTLE trial) and for venous thromboembolism prevention. Apixaban recently was found to provide as significant as a 54% reduction in stroke or systemic embolism compared with aspirin in patients with atrial fibrillation who were unsuitable for warfarin. The ongoing studies will continue in non-ACS indications, says Bob Harrington, MD, FACC, co-chair of the APPRAISE-2 Steering Committee and a member of the ACC Board of Trustees. He notes that concerns about apixaban only extend to the high-risk ACS patients who were enrolled in the APPRAISE-2 study.

Implications
This trial was the first large trial to report on the combination of an anticoagulant on top of aspirin and/or clopidogrel.  Three Phase II trials so far have shown that there is a tight balance of efficacy to safety (APPRAISE I, ATLAS-ACS TIMI 46, and RE-DEEM). We have all been wary of triple therapy... we know that the combination of ASA, clopiodgrel and warfarin has increased risk of bleeding, and now we see similar issues of increased risk of bleeding with adding an oral Xa inhibitor. Ongoing trials with different agents will see if there can be a benefit with an acceptable bleeding risk.

As an indication of the incredible functionality of the lame duck Congress, lawmakers managed to leave for yet another vacation without extending the moratorium on the SGRrrr. What should we have expected? Actually, the Senate last night approved a 31-day extension – that’s right, a whole month, with the idea that they will come back after Thanksgiving and attempt to add an additional year of moratorium. This would get the moratorium extension to extend through January 2012. The House, however, was awfully tired after a week of work and needed to get some shopping done before the holiday, decided to recess without acting on their side. The comment was that when they get back after the Thanksgiving holiday on Nov. 29, they have a whole day to get this done before the cuts kick in Dec. 1. Plenty of time. This duck doesn’t seem to fly.

ACC Prez Ralph Brindis got some great air time in the papers on this topic yesterday in Inside Health Policy. He said:

“Give our patients something to be thankful for.... The looming threat of a 23-percent cut can’t become reality to the millions of Americans fighting heart disease nor to the thousands of cardiologists treating them.”

 “The ACC will continue to push for meaning payment reforms that repeal the SGR and put into place innovative solutions that reward quality care and patient-centered outcomes. Until then, Congress must act quickly to stop these devastating cuts from taking effect on Dec. 1.”

Yesterday I had the pleasure of stopping by the Council on Cardiovascular Care in Older Adults meeting. This council, led by Daniel Forman, MD, FACC, of Brigham and Women’s Hospital, is composed of cardiovascular professional leaders with a passion for optimizing care for older adults. Its purpose is to provide education, support research and conduct advocacy on behalf of geriatric cardiology.

This area is growing in importance. There are currently 40 million adults age 65 and older, and this is predicted to grow to over 70 million by 2030. This is especially worrisome given that this population is predisposed to CV disease. Although from the outside, it may seem that cardiology and geriatric cardiology are one and the same, in fact, care for older patients -- generally considered those 70 years and older -- requires special consideration compared to treating younger patients.

When treating older patients, their age affects the whole range of their medical care -- from the syndromes that occur in older adults, like frailty and cognitive impairment, to metabolic changes that affect how they process drugs, to changes in physiology, like isolated systolic hypertension, syncope, and heart failure with normal systolic function. When treating older adults, there a shift in how you think about care. Because of the high potential for comorbidities and complicated drug regimes, cardiovascular professionals have to take a more holistic stance to providing care. In addition, shared decision making, involving patients and their families in choosing among their therapeutic options, should ideally be incorporated in our care of the elderly.

Given its importance, the Council on CV Care in Older Adults is trying to get more cardiologists and CV professionals interested in geriatric cardiology. Ways in which they can do this was one of the main topics of the council meeting today. One of the approaches they’re currently using is providing an educational curriculum for Fellows in Training that raises awareness of age-specific changes and how they impact disease assessment and management. You can learn more about the curriculum in the YouTube video below.

What are your thoughts on the differences in care between younger and older cardiology patients? Do you have suggestions for the council on how they can raise awareness?

ACC's leadership is in Chicago for AHA's meeting, and working hard for our members. We're representing ACC at international events such a the meeting of the American Association of Cardiologists of Indian Origin. When my wife and I retired from the meetings for a quiet Sunday evening dinner, Jack Lewin and former ACC President Fred Bove led into the restaurant an ACC contingent that spilled over discussions from the JACC Journals Reception earlier in the evening.

Late breaking clinical trials presented yesterday at AHA -- including ASCEND-HF, RAFT, ADVANCE and EMPHASIS-HF -- are nicely summarized on CardioSource for those not in Chicago. There were more late breaking trials today, as well as an interesting session chaired by ACC BOT Elliot Antman that will cover regulatory issues that intersect with the clinical use of clopidogrel and warfarin.

Today I met briefly with the NCDR and the Society of Thoracic Surgeons database leadership team. The NCDR (National Cardiovascular Data Registry) continues to be the most comprehensive, outcomes-based quality improvement program in the U.S. NCDR over the last couple of years has grown exponentially, to offer not only several hospital-based registries (covering ACS, carotid artery resvacs and endarterectomy procedures, diagnostic cath and PCI, and ICDs) but also the first-ever CV practice-based registry, PINNACLE. PINNACLE collects data on practice performance on CAD, hypertension, HF and AFib, and then provides practices with quarterly benchmark reports that can help them to improve performance.

ACC’s newest registry actually launched officially just last week. The IMPACT Registry will assess the prevalence, demographics, management and outcomes of pediatric and adult patients with congenital heart disease who are undergoing diagnostic catheterizations and catheter-based interventions. This registry is groundbreaking – to date, no single registry has collected sufficient national quality-focused data in this area. Its data will provide significant contributions to the knowledge base and outcomes associated with congenital heart disease.

Today’s meeting confirms what everyone who works with NCDR knows: because NCDR collects real-world data, it is uniquely positioned to help participating facilities and medical professionals identify and close gaps in quality of care, reduce wasteful and inefficient care variations and implement effective, continuous quality improvement processes.

Registry data is the future of measurement. For every trial that relies on error-fraught claims data, we need to replace it with the outcomes-based data that NCDR provides. This will help us understand what is actually happening in CV care.

AHA will feature a record number of abstracts with NCDR data. You should check them out if you’re interested in seeing how the data can be applied. Here’s a PDF listing of times and locations.

This morning I went to a meeting on the “Do’s and Don’ts of Comparative Effectiveness Research.” Comparative Effectiveness Research, also called CER, has been the topic of much discussion since it was included in the stimulus package (American Recovery and Reinvestment Act of 2009). CER is a topic that has been discussed extensively on the ACC in Touch Blog, in part because it’s such a hot topic and in part because how it’s structured in the future could have wide-sweeping impacts on the practice of medicine.

Why so? Clearly, understanding the relative benefits and harms of two treatments is beneficial to providing the highest quality of care possible. CER has the potential to provide valuable information on the relative value of competing drugs, devices and treatment strategies, which in turn could improve outcomes, efficiency and satisfaction.

However, where the controversy comes in is how this ties into reimbursement for drugs or treatment options. If Drug A is superior for most patients than Drug B, then there is the potential that Drug B could stop being reimbursed by Medicare, which then may trickle down to private insurers. This isn’t problematic for the large majority of patients who benefit from Drug A – but what about the minority of patients who actual do better on Drug B? Should they have higher drug costs because they’re in the minority?

It’s the tie between money and effectiveness that’s at the root of the issue, and it continues to be a hot topic as evidenced from this morning’s meeting. In addition, the quality of the trials conducted – given their wide-reaching implications – is of utmost importance. The trials need to stand up to the strictest research standards to ensure that the findings are able to reflect what’s actually happening in the population.

The ACC wholeheartedly support CER for the value it will add to our cardiovascular knowledge, but recognizes the potential for it to be used to deny coverage. That’s why in 2009, the ACC released an advocacy position statement on CER, articulating where we stand on the issue. Its main findings:

• The ACC strongly supports CER as a way of having informed decision-making.
• CER priorities should be set by a multi-stakeholder group to ensure that the research agenda reflects the needs of the country. The research agenda should be based the burden of the disease being considered, mainly morbidity and mortality.
• The ACC recognizes that the research on comparative effectiveness is “only the first step in improving the quality, equity and efficiency of medical care,” and stresses that improving quality must be the primary aim of CER.
• CER should be distinct from entities that create coverage and benefit programs, and requires close monitoring to avoid adverse consequences on access, quality or safety.
• The ACC recognizes that CER will require substantial and long-term financial support.

The policy statement concludes: “The ACC believes CER research, when conducted correctly, is a useful tool that assists physicians and other providers in delivering high-quality, equitable and effective health care to patients.”

CER MUST separate cost efficiency from clinical effectiveness. Not only is this necessary to ensure coverage for all patients, it also is necessary to maintain physician and patient trust that CER is untainted scientifically from societal/government pressure to reduce costs.

Below are some related resources if you’re interested in learning more about CER, including a video on shot at one of last year’s Medical Directors Institutes. I’m interested to hear your views on CER in the comments section below.

• ACC 2009 Advocacy Position Statement: Principles for CER
• Guest blog post from former ACC Chapter President John Brush, MD, FACC on how he feel CER should be structured
• All past blog posts on comparative effectiveness