Today the Journal of the American Medical Association released an article about the importance of funding clinical research, including comparative effectiveness research, to determine the best ways to diagnose and treat heart disease. We at the ACC could not agree more. In fact, one of our staff members is an author of the article, by Drs.Tricoci, Sid Smith and Rob Califf, and our own ACC Joe Allen. The paper sends an important message to the new Administration, Congress and the nation about the need to invest more in science, medical evidence and clinical comparative effectiveness. To turbocharge the guidelines we need a vast amount of new research and evidence! $1.1 billion for comparative effectiveness research and $10 billion for NIH is a start.

Unfortunately, accompanying the article is a disturbing JAMA editorial. The editorial suggests that ACC/American Heart Association clinical practice guidelines lack critical evidence support, despite the fact that they are by far the best evidence at our disposal — and we want more evidence to build more guidelines! Plus these authors suggest guidelines are “cookbooks.” Rather, they offer learning system opportunities to document when and where care should depart from a guideline for a given patient, helping to accumulate data on when and how guidelines need to be updated. No patient perfectly conforms to a guideline, but where is there better science to use to manage care?

The ACC/AHA clinical practice guidelines offer guidance to help health care providers determine the best treatment options for their patients.  These guidelines are developed after careful analysis of the strongest clinical trial evidence available at the time.  In some cases, however, evidence is limited or not available, so some recommendations are based on the consensus agreement of a panel of leading experts in the field of heart disease care.  Once drafted, the guidelines go through substantial peer review and content review by clinicians and scientists at the highest levels of each organization.  The published guidelines represent a product of academic and clinical commentary from a large group of the best minds in the field.

These outstanding guidelines have helped cardiovascular specialists make significant progress in the battle against heart disease. We introduced the first guidelines 25 years ago, and coronary heart disease death rates have fallen by more than 30 percent in the past decade alone. President Doug Weaver was interviewed by WSJ and USA Today, and Board VP Ralph Brindis was interviewed on this by the New York Times.

ACC President Doug Weaver says, “The editorial implies that we should go back 30 years to when a thousand different physicians made a thousand different care plans based on their personal judgments, biases and even lack of knowledge of rigorous scientific findings.” Dr. Weaver is absolutely right. To ignore the ACC/AHA guidelines would introduce even more variation in care than already exists in our health care system.

We DO need more research! But we must continue to apply the best evidence we have diligently NOW until that wonderful day when we have irrefutable evidence for most of what we do.

Please share your thoughts on the article, the editorial and the need for evidence-based guidelines by leaving a comment. Also, check out the recent commentary on guidelines from Immediate-past President Jim Dove, M.D., M.A.C.C.

Still no real word on the Secretary of HHS. Governor Sebelius of Kansas is being background vetted, so may be #1 choice. Ted Kennedy has come out for her.  But no word really. The FDA job seems down to Margaret Hamburg, M.D., former NYC Commissioner of Health, and Baltimore Health Commissioner Scharfstein (Kennedy’s favorite), and former Henry Waxman (D-Calif.) staff person. Hamburg is a very effective person. Everything else seems on hold still.

*** Kathleen Sebelius. Image from Wikimedia Commons (Dayton Mitchell) ***

Some of our members are working so hard -- heads down -- diligently taking care of their patients -- that they are genuinely curious and seemingly not yet fully aware about what’s going on (threats and opportunities) here in the Capitol these days. ACC officers and I are frequently asked when we are out in the Chapters "why is ACC so engaged in the health system reform issues?"  It’s amazing to us. But it’s also hard to get the message out effectively to the grass roots about how fast things could possibly (or possibly NOT) move in these reform discussions this year. But, to give you an idea — here are just a few of the things cooking here this coming week alone:

• Discussions of the federal budget and health reform are likely to dominate the week, with various meetings and discussions in Congress and CBO (this will have implications for us folks).
• President Obama has convened a Fiscal Responsibility Summit today at the White House, followed by a presidential address to Congress on Tuesday night that will focus in large part on what to do about the looming Medicare projected shortfalls (5 times larger than the Social Security deficits);
• The Office of Management and Budget (OMB) will release of a budget framework on Thursday – including all of CMS’ new projections on the nation’s health spending Monday (again, these will be critical for medicine!).
• Meanwhile, both the Senate Finance Committee and the Senate Health, Education, Labor and Pensions Committee (HELP) again turn their attention to health reform with hearings next week (believe me, we need to monitor and react immediately to this stuff for all of you out there!). The topics are--
  • Senate HELP Hearing (2/24) – The Health, Education, Labor and Pensions Committee holds a hearing to examine the issue of the underinsured in the context of health reform.         
  • Senate Finance Hearing (2/25) – The Finance Committee holds a hearing with CBO Director Elmendorf to examine scoring issues and budget options for health reform, including physician payment and SGR reform.
• Healthy People 2020 – The HHS Advisory Committee on National Health Promotion today meets to discuss efforts to promote healthy lifestyles and prevent disease, with a particular focus on CV disease. 
• The CMS will hold Open Door Forums on rural issues on Tuesday and on hospital and hospital quality issues on Wednesday.

This doesn’t include what the private sector activities are. IOM is having meetings this week on various quality related topics as well. Busy week!

But all of you need to plan to set up a meeting with your own members of Congress later this spring. Start scheduling the meetings now for April or May in your district offices. There will be plenty to talk about!!!! And, we’ll help you with talking points on key issues. Of course, plenty’s happening in all your state legislatures as well at the same time. Whew!

Going after the $20 billion for health information technology (IT), $1 billion for comparative effectiveness research, $10 billion for NIH clinical research, and $2 – $3 billion for prevention activities in the stimulus bill (ARRA) will be a big-time goal for many organizations. It’s time to get in there and grab some dough. The competition for dollars will be fierce, but we have some very sound ideas about how to spend stimulus funds for quality health care. There is an opportunity for registries to be piloted for quality improvement activities. There is still no reimbursement “business case” proposed, but that too could be piloted. Our academic colleagues need to get ready to go after the NIH dollars as well.

The comparative effectiveness research (CER) piece is probably the most controversial. Frankly we would need $1 B annually for 20 years to really get serious about having the massive amounts of additional evidence we need for turbocharging guidelines, performance measures and appropriate use criteria.

Separating cost effectiveness from clinical effectiveness is key to de-politicizing the CER process. Cost effectiveness is critical, but it needs to be done once an objective clinical effectiveness process is completed around any topic. The ACC strongly supports clinical CER. But, one of the risks here -- as shared this week by Avalere Health is that some observers see CER as a way for the federal government to take complete control over guidelines, performance measures and appropriate use criteria. AHRQ shares openly how they did not succeed well in this, when they did try engaging in guideline development a few years back. It costs them too much to produce what we can do with mostly volunteer FACC and researcher efforts; and they got hung up in dangerous political issues in the Congress when various elements of industry didn’t like their results. Better to have a federal agency like NQF or AHRQ look over the shoulders of the profession to vet our guideline efforts, which are bound to be more trustworthy to physicians, and therefore more widely adopted.

Stay tuned, and be certain ACC will be centrally involved in pushing for the best, most objective, and patient centered evidence. We need more of it -- and it’s a important part of the profession’s accountability -- to lead in making that happen! Importantly, we need to clarify to the confused that guidelines are not rigid cookbooks -- see the post last week from ACC past president Jim Dove.

*** Obama signs ARRA into law. Image from Wikimedia Commons (Pete Souza) ***

I see physician payment reform as the biggest threat and opportunity of the year. There is growing consensus among policy wonks, members of Congress, and others that fee-for-service (FFS) medicine has to be replaced with something better. But what?

One thing for sure -- that most physicians do not understand -- is that non E & M FFS payments are being “nickel and dime’d” downward slowly-but-surely to make FFS payment less attractive and less viable. It is a plot. The recent and likely future actions of the RUC in these regards to inexorably whittle down procedure and diagnostic services payments under pressure from CMS contribute to this. The entire RBRVS readjustment processes are undermining gradually FFS, although there have been some modest increases in E & M payments, but not enough to make primary care viable.

Since most of the waste in health care costs is still in unnecessary or avoidable inpatient care, if there was a way to ‘gainshare’ with hospitals when physicians reduce unnecessary spending or admissions, there would be resources for significant pay increases in a reformed payment system in which both society and patients win, and real savings are achieved. But, the hospitals are the losers in that scenario, making it tough to get going. More...

The ACC today sent an all-member alert on Tuesday’s stimulus package (also known as ARRA). Given the ACC stance on health IT, it recommends that “members who do not currently use an EHR begin the process of adoption in 2009 and implement a system no later than 2010 in order to receive the maximum bonuses available under the program...”

...Concluding:

Given the many benefits of using health IT, including reduced administrative cost and medical errors, the ACC highly encourages members to take advantage of the federal funding available from 2011-2015. The funding can significantly offset the cost of adopting this technology.

Check out an ACC summary of the law.

***Image from Flickr (Prasan Naik)*** 

This post comes from ACC immediate past President James Dove, M.D., M.A.C.C. Dr. Dove is a clinical professor of medicine, Division of Cardiology, at Southern Illinois University, and a founding partner of Prairie Cardiovascular Consultants, Ltd., a 42-member group of cardiologists. As president, Dr. Dove set in motion ACC's efforts in implement quality in cardiovascular care.

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For 25 years, the American College of Cardiology Foundation and the American Heart Association have produced clinical practice guidelines.  These guidelines carefully review the available evidence, rank the importance and significance of major trials and the voluminous medical literature. The results are lengthy guidelines with a series of recommendations, classified as I, IIa, IIb, and III, depending on the strength of the recommendations.

The documents are a wonderful distillation of the literature and serve as a tremendous resource guide to practitioners.  They are, however, difficult to apply at the bedside.  Numerous attempts have been made by the College to help address that difficulty.  Wall charts, pocket guides and other tools have been produced in an effort to facilitate clinical application.  These processes, while helpful, have failed in the application of the Class I guideline recommendations 100% of the time in every patient in whom the recommendations are appropriate.

Best practices in the future will use computer decision-support tools (CDS) that function well within the clinical workflow and facilitate decision-making as well as providing reminders at the point of care.  These tools can also automatically collect process measures without requiring additional time-consuming chart reviews.  Computer decision-support tools will allow us to apply the guidelines every time to every patient for whom the guideline is appropriate and to document clearly the reasons a specific recommendation is not appropriate for a given patient.

The time is now to adopt and develop these computer decision-support tools to function at the point of care, document quality and facilitate our adherence to best medical practices. 

This is not cookbook medicine – instead, it allows us for the first time to effectively collect data about adherence to guidelines, appropriate deviations from guidelines, and eventual correlation of process measures and the effects of those measures on clinical outcomes.   There is no better way to document the significance of process measures of all classification levels than to do so at the point of care and correlate that information with clinical outcome in thousands of patients.

- By James Dove, M.D., M.A.C.C., ACC immediate past president

* Dr. Dove's post is the fourth in a new monthly series of guest posts by ACC leadership. Check back next month to see which ACC leader is sharing his or her thoughts on health care reform!

Who will be the new Secretary for HHS? No word on whether Governor Sibelius is interested. Even if so, she might need a couple of years to get the hang of Congress. Dr. Dean has a lot of naysayers. John Podesta, the Obama Transition Chief of Staff is seen as ready to move on the issue, but I’m not hearing much more on his name a week later.

Personally, my choice of a surprise candidate would be Ahnold! Seriously. Governor Schwarzenegger is a moderate Republican, married to Ted Kennedy’s niece, whose recent health system plan was patterned very much like Massachusetts, the Obama principles, and the Baucus plan. With Senator Gregg’s resignation, the President needs another R member of the Cabinet. Arnold’s smart. And who could better strong arm the Congress, grab the public’s attention, and have some real-world experience with how tough this is than Arnold? Start the rumor campaign.

The City of Milan, Italy, is pressing legal charges against current and former Google employees and the company itself for violating the privacy of a teenager with Down Syndrome. Two years ago, someone posted cell phone video of a few teenagers bullying a 17-year-old with Down Syndrome from Turin, Italy. Google pulled the video after receiving complaints, but prosecutors say the company should never have allowed the video in the first place. Google officials contend that the search engine giant is a neutral platform and is not governed by privacy laws.

A study from the Commonwealth Fund published in Health Policy finds the U.S. lagging behind other developed nations in adoption of health information technology (IT). Only about 28 percent of U.S. physicians are using electronic medical records, vs. nearly all physicians in the Netherlands, and higher percentages in most other developed nations.

The study also shows that physicians who have adopted health IT consider themselves better prepared than non-adopters to treat patients with chronic disease. The Commonwealth Fund suggests we need federal leadership to encourage physicians to get on the bandwagon. No kidding. Let’s hope the provisions in the stimulus package go through, but we need reform that provides real incentives for HIT adoption.