The ACC is asking Congress to stop a huge cut to Medicare physician reimbursement as a result of the sustainable growth rate formula, which is required by law to go into effect on Jan. 1, 2012.

If you feel like you’ve read that sentence before, it’s because you have – the ACC has been fighting similar cuts to the SGR every year since 2002. In the last few years, we’ve added “repeal the SGR formula” to that list. Here are my top four reasons why the SGR needs to be permanently repealed:

1.       This year’s cut totals 29.5% of payment. That’s nearly a 1/3 cut in pay and will effectively kill Medicare access for many patients.

2.       Every year since 2002, Congress has stepped in to overturn the SGR cut. Last year, they repealed the SGR cut four times. This certainly is not efficient.

3.       Physicians need stability in payment. We need to know at what level we’re going to be paid, and not have to worry that one year our payment may be cut drastically. This helps us plan for infrastructure and other investments in our practices.

4.       The longer Congress waits to repeal the SGR, the more it costs. If Congress were to repeal the SGR formula this year, it would cost nearly $300 billion over 10 years. If it just waits five more years, then repealing the formula will cost half a trillion dollars.

The ACC has joined a multi-specialty effort to repeal the SGR. As part of this effort, the College is urging Congress to act before Thanksgiving to provide a positive update with at least 13-months of stability through 2011. This short-term fix would allow the new Congress to sort through various options aimed at putting the Medicare SGR physician payment formula on a pathway toward permanent repeal. The ACC is asking its members to contact members of both the House and Senate and urge immediate action.

Additionally, the SGR will be discussed in detail at the 2011 Legislative Conference, to be held Sept. 11-13 in Washington, D.C.  The conference will commence on Sunday with a reception and dinner featuring General Stanley McChrystal. Monday will be filled with educational sessions on topics ranging from health reform implementation and innovative payment models to the impacts of regulatory changes on the practice of cardiology. Len Nichols will be the keynote speaker at Monday’s lunch.  Nichols is the editor-in-chief for ACC’s upcoming Payment Innovation Community, which will launch in September on CardioSource. On Tuesday, conference participants will head to Capitol Hill for pre-arranged meetings with their members of Congress.  Registration closes August 5, so make sure to register now if you’d like to attend.

For more background on the SGR cuts and why repeal is critical, watch the video below, which was produced as part of the multi-specialty efforts.

The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee on Wednesday voted to recommend approval of the Edwards SAPIEN Transcatheter Heart Valve. The Edwards valve was tested in the PARTNER trial, which examined its effectiveness in inoperable patients with severe aortic stenosis. PARTNER found that transcatheter aortic replacement (TAVR) significantly reduced symptomatic mortality and composite endpoints at one year compared to medical therapy for specific patient populations (particularly the elderly with multiple comorbidities). FDA is not required to follow the recommendations of its panels, but typically does.

I spoke at the meeting, as did Michael Mack, MD, president of the Society of Thoracic Surgeons (STS), Gus Picard, MD, from the Society for Cardiovascular Angiography and Interventions and others prominent in this field. On the panel was Rick Page (chair), chair of ACC’s EP Committee and immediate past president of ACC Ralph Brindis, MD, MACC. There were many other ACC members in attendance as well.

During my comments, I outlined ACC’s recommendations for rational dispersion and post-market surveillance of the Edwards device. The ACC believes that dispersion will rely of three key players: Edwards, in educating physicians on how to properly use this specific device; the ACC, STS and other applicable specialty societies, in educating physicians about the particular disease state and therapeutic options; and the government, which must facilitate interactions and collaboration among all involved. In these modern times, novel implantable devices, such as the Edwards valve, require that relations between federal agencies and professional societies be revisited with a creative and visionary eye.

My comments stressed practical elements that will be required to ensure that implementation of TAVR improves quality. First and foremost, the procedure must be completed by a multi-disciplinary team; no one subspecialty should perform TAVR alone. Additionally, because patient selection is so important, there must be further development of the criteria used for patient selection. In terms of facilities, the ACC supports the development of centers with specialized expertise in TAVR.  This is based upon the literature that has indicated that structural heart disease outcomes have a direct relationship to center procedure volume. Finally, the ACC recommends tracking patient outcomes and safety through a registry for valvular heart disease, created by linking clinical and administrative databases.

There was also detailed discussion of the risk-benefit ratio in terms of periprocedural stroke.  This in-depth discussion extended the information available in the published trial.  The panel included experts in the field of stroke, and there was much discussion on the etiology of the stroke and development of preventive strategies.

In addition, there was detailed discussion of the issue of patients who might be too grail or who have such extensive comorbidities that they would not benefit from the procedure.  Better patient selection criteria are needed to identify patients who are too frail, in whom intervention may be futile.

Following the hearing, the Advisory Committee voted on three main questions:

1. In a vote of 7-3, the committee agreed there was "reasonable assurance that the Edwards SAPIEN™ Transcatheter Heart Valve is safe for use in patients with severe aortic stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis."
2. In a vote of 9-1, the committee said there is "reasonable assurance that the Edwards SAPIEN™ Transcatheter Heart Valve is effective for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication." 
3.  In a vote of 9-0-1, the committee said the "benefits of the Edwards SAPIEN™ Transcatheter Heart Valve for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication outweigh the risks of the Edwards SAPIEN™ Transcatheter Heart Valve for use in patients with severe aortic stenosis who meet the criteria specified in the proposed indication."

The ACC submitted written comments in advance of the panel meeting as well. The ACC and STS in June released an overview document of transcatheter valve therapy, and it is the first of a series of documents that will address the issues critical to successful integration of TAVR into medical practice. Look here and to CardioSource for more as these documents are released. For more on the initial overview document and PARTNER results, see my previous blog.

Here’s the video again:

Pediatric devices get a lot less attention than is deserved. On Thursday, the FDA Circulatory System Devices Panel considered a request for a humanitarian device exemption of Berlin Heart, Inc. for its EXCOR Pediatric Ventricular Assist Device (VAD). While the literature documents potential risks to the implantation of VADs in the pediatric population, it also indicates opportunities to extend the time limits of existing therapy.

The ACC submitted comments in advance of the meeting, which note the importance of device manufacturers venturing into the field of pediatric devices because of the limited number of treatment options for pediatric cardiology patients in need of a bridge to transplant.  The ACC also attended the meeting.

The panel voted unanimously to in favor of all three questions posed:

1.       “Is there reasonable assurance that [it] is safe for use …?”

2.       “Is there reasonable assurance that [it] provides probable benefit …?”

3.      “Do the benefits … outweigh the risks …?”

The panel’s recommendation of a humanitarian device exemption for the EXCOR device is a breakthrough for pediatric cardiology. The device is really the only one small enough to use in infants and small children. The FDA still must adopt the panel’s recommendations, but we are pleased with the outcome and will continue to work with FDA to support these efforts.

This post was authored by former ACC President Alfred Bove, MD, PhD, MACC.

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Recently, the Wall Street Journal profiled former vice president Dick Cheney’s 33-year battle with heart disease. Cheney has had five heart attacks and had a left ventricular assist device (LVAD) implanted a year ago. Cheney’s medical history is a fascinating story of the combination of technology and perseverance. Quite simply, he owes his life to cardiovascular innovation.

It’s hard to believe the advances we have seen in the last 60 years. As Cheney recounts in WSJ, life-saving techniques for MI back in the 1950s were limited, something he experienced first-hand with the death of his grandfather from a heart attack. Unlike his grandfather though, the vice president has received numerous cutting-edge procedures throughout the years that have kept him alive and working in Washington, up until his recent retirement.

Because of advances in medication, new devices to improve heart function, and interventional procedures, both surgical and non-invasive, deaths from heart disease have shown a significant decline over the past 10-15 years. While there is a clear decline in mortality, the rate of myocardial infarctions (MI) has not shown this same reduction.  The data reflects the fact that because we have improved MI survival, we now have a large population of patients with chronic heart disease, often with late-stage heart failure.  Between 60-70% of patients with late-stage heart failure have hearts that were damaged by one or more MIs.

A significant number of patients with late-stage heart failure are now considered for heart transplant. However, due to the scarcity of donor hearts (less than 3,000 for a pool of more than 30,000 eligible patients in the U.S.), mechanical pumps, once considered a rare application, have found their place in the mainstream care of end-stage heart failure patients.  LVADs, once solely implanted in patients awaiting heart transplant, have increasingly replaced the need for transplants and are now a long-term option. They have allowed some patients to avoid the complex medication regimens and surgical complications that accompany a heart transplant. These devices may even replace the heart completely in the future, a thought that is fascinating for the future of our profession.  The advances in bearing technology, including the replacement of cyclic with continuous flow pumps, the reduction in size and conversion from pneumatic to electric power, have made LVADs a feasible therapy for these patients.  The technologic advances have extended pump lifespan from 1-2 years to 4-5 years and allowed patients to return to a full and active life with the device providing a significant portion of the cardiac output to assist the weakened left ventricle. 

Engineering research continues in the areas of smaller pumps; induction-charged batteries that can be implanted to eliminate the skin breach for power wires that often leads to infection; and smaller incisions for implantation.  There is even early research on VAD implantation using percutaneous techniques.  Medical care is advancing to better understand the bleeding complications related to clotting factor changes, prevention of infections and pump settings to optimize function and minimize complications.  Fully computerized pump control will eventually adjust the pump to exercise, rest, sleep and other unique demand situations.

As with any other new medical technology, these advances come at a price. With health care costs escalating each year, and cardiology accounting for a significant portion of the Medicare budget, there is much debate about how widespread innovative cardiac devices and procedures, such as LVADs, should be. For patients who return to productive lives with an LVAD, the overall cost may well be reasonable considering the return to productivity and the reduced long-term cost of care for severe heart failure. As more patients who will not receive a heart transplant are provided with destination LVADS, the cost analysis is likely to be favorable for LVAD use. However, they are still likely to generate considerable debate on the ethics of their use in an already overburdened health care system. Given the fact that most of the patients who need an LVAD have hearts damaged by coronary disease, we may see a push to reduce demand by achieving higher levels of prevention.

Of all the provisions of the Affordable Care Act (ACA), probably the 2nd most controversial one after the individual mandate is the IPAB (Independent Payment Advisory Board). IPAB creates a board of 15 members that could set payment rates for Medicare services. The members all get paid a government salary and can have NO other outside work. The rates they set do not have to be approved by Congress and the IPAB doesn’t have to have any physicians—or patients—as members. Its cost-cutting proposals must be implemented unless Congress adopts alternative proposals achieving equivalent levels of savings.

The ACC had a tremendous opportunity this week to be invited to testify at the House Energy & Commerce Committee hearing on IPAB. What an opportunity!

First and foremost, I told the committee that the ACC fully supports the purpose of IPAB. It is essential to get health care cost increases reined in to protect national, personal and business affordability! Early in the health reform debate, the College hoped the IPAB concept would evolve into an opportunity to break down the silos of parts A and B in Medicare and modernize the program by focusing on quality improvement.  Our problem is that the current structure of IPAB will not do that, and will have many unintended and negative effects on health care. It will save no money through price controls but it will reduce access to care for lower-income people, and will negatively affect all Medicare beneficiaries’ access to high-quality care.

The basic gist of my testimony was that significant modifications are necessary. Preferably scrap the IPAB, or amend the heck out of it into something that adds value was my message. The ACC believes IPAB must place more emphasis on payment reforms that improve quality and lower costs rather than price controls that could hurt access—and as history proves—won’t work.

Furthermore, the ACC believes that Congress must first act to permanently repeal the flawed sustainable growth rate (SGRrrr) formula used to set Medicare physician payment rates prior to contemplating the IPAB “fix.” Physicians are already subject to an expenditure target and other potential payment reductions as the result of the SGR. It doesn’t make sense to subject physicians to expenditure targets while at the same time exempting from IPAB’s recommendations large segments of Medicare providers who are subject to no target at all. Until the SGR is replaced, the ACC cannot support implementation of IPAB---which first must be amended to be something different and effective.

There’s a video of the hearing on YouTube (embedded below). Unfortunately, while my voice carried well, my microphone was off while I was giving my testimony. Check out 4hr:20min recording point for the question-and-answer session, where I fielded questions from several committee members with the microphone actually working.

During the Q&A, I had the opportunity to emphasize ACC’s support for the Center for Medicare and Medicaid Innovation and highlight the quality improvement initiatives underway at the ACC, including the PINNACLE Registry. My written testimony is on CardioSource, but I departed from it significantly to be more emphatic and respond to issues raised by other testifiers.

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 proposed 2012 Medicare Physician Payment Rule (formally called the Physician Fee Schedule) was issued just before the 4th of July weekend at 4:15 p.m. Friday. Why? So nobody will have time to read it and comment and complain until this week. The 2010 payment rule was devastatingly bad. The 2011 rule was nowhere near as bad as that, and this one for 2012 is not full of apparent surprises. The 2012 rule has the third year of residual cuts that originated in 2010, but the impact next year averages out about negative 1%. The big impact would be the SGR cut of 29.5% if it were not waived -- which it will be for a year at least I presume.

Here are some of the highlights from our initial review (more coming later this week):

• Imaging Payment Reductions: CMS proposes to reduce the payment by 50 percent for the professional component of certain imaging services provided at the same session on the same day by the same physician.
  
  
• Electronic Prescribing Penalty: By law, CMS is required to reduce Medicare payments to those practitioners who do not electronically prescribe and for whom at least 10 percent of their Medicare payments are associated with certain types of office visits. As part of the 2012 proposed rule, CMS is considering providing practitioners with an additional opportunity to avoid the penalty.
  
  
• Potentially Misvalued Services: CMS identifies three cardiology codes for review as potentially misvalued. Data for cardiovascular stress test (93015), extracranial study (93880), and complete electrocardiogram (93000), will be reviewed by the RUC for presentation to CMS before July 2012.
  
  
• Physician Compare and Value-Based Purchasing: CMS proposes another step towards the required implementation of value-based purchasing in 2015. In the proposed rule, CMS includes a series of claims-based measures that will be used to report on physician quality using the new Physician Compare website. In addition, CMS proposes a series of quality measures that will be used to adjust payment based on quality starting in 2015.
  
  
• Physician Quality Reporting System (PQRS) and Maintenance of Certification (MOC): CMS proposes some changes to PQRS but largely keeps intact the registry reporting that is commonly used by cardiologists. Physicians that successfully participate in PQRS in 2012 will receive a 0.5 percent bonus of Medicare payments.
  
  
• Coding: CMS, as expected, continues to move forward with bundling payments for certain services. Specific changes will not be available until November.

Read the full initial review on CardioSource.

I’ve attended several discussions and think tanks this year that were focusing on needed changes in the future of health care as part of system reform that include newer concepts not usually front and central in reform deliberations. Concepts like personalized medicine, systems biology, integrative medicine, evidence-based medicine, learning health care systems, the chronic care model, and prospective medicine come to mind as sub-themes to the larger reform discussion that tend to be under-emphasized. Underlying a great deal of these conversations and concepts is a perceived need to rediscover the art of medicine, and rebalance it with the science.  I strongly support this need.

“Functional medicine,” which would put all the aforementioned ideas into an interwoven common structure, was discussed at a meeting at Harvard I recently attended, and has been promoted by a new Institute for Functional Medicine. There are others exploring these ideas at various institutions. The concept would try to achieve a better understanding of an urgent problem facing clinicians today -- in particular with respect to managing complex chronic illnesses -- how to combine the science and the art, and the evidence and insight into a personalized, patient-centered approach. This would obviously include shared decision-making as a central premise.

Looking at the increasing chronic disease crisis involving diabetes, obesity, CV disease, cancer, and many other conditions, the new mantra is that much of this could be reduced by changes in lifestyle, implying then that patient responsibility and self care are the key ways to address this. But a lot of lifestyle factors are beyond the control of individual patients -- not just genetics, but also exposure to toxic environments, fragmented families, poverty, communities without fresh foods or safe places to exercise easily, etc. The transformation of health care from the acute care model to a more effective chronic disease model will succeed only if we attack the drivers of the growing epidemic -- the complex interactions of lifestyles, environmental factors, and genetics. We’re seeking here a new approach to 'healing partnerships' between clinicians and patients -- team practice is a big start in that direction. But we need a new set of care delivery models that incorporate these concepts into medical training and education, clinical practice and research.

ACC Past President Fred Bove, MACC, launched our College efforts in these regards two years ago; and President Elect Bill Zoghbi, FACC, will focus on this challenge of creating a patient-centered care model for cardiology care as his theme in 2012. We’ve made major progress. Our CardioSmart patient website and Patient-Centered Care Committee and the new outreach models we are testing are exciting beginnings. But they are just beginnings. Improving health care, improving health, and lowering costs -- the triple aim -- will require new partnerships with patients and society to succeed, and new ways to transform care.