August 13th, 2012
Universal Screening for Dyslipidemia in Children: A Debate with Equipoise, but Tarnished by Industry Influence
William O Roberts, MD, MS
Note: This post is accompanied by a separate post from Larry Husten, and a counterpoint post from Samuel Gidding.
As a strong proponent of heart and vascular disease prevention and a parent of two teenagers, I have watched closely the debate about the new pediatric lipid guideline recommendation for universal lipid screening at ages 9-11 years. The physicians and researchers on both sides of issue are intelligent, thoughtful, and honest advocates for their positions regarding universal screening, a question that truly has scientific equipoise. In this post, I will briefly describe my position, and hopefully sound a clarion about the influence of the medical industry on this debate. My discussion of industry’s role will emphasize evidence from the social science literature about conflicts of interest, so we can move beyond name-calling, moralizing, and emotional responses to this serious issue.
Universal Screening for Dyslipidemia in Children
I oppose universal lipid screening for children, primarily for the reason that Matt Gilman so eloquently described: because “the harms of screening fall disproportionately on the healthy.” To be clear, the potential harms of universal lipid screening in children, just like its potential benefits, have never been proven. So we are operating in a data vacuum and have scientific equipoise. What are the potential harms? First, increased medical costs, which are born by society, and second, the “medicalization” of lipid values that make children at no short- or even intermediate-term risk of cardiovascular disease (CVD) events, in some way, abnormal. Risks of “medicalization” include stigmatization, labeling, and the practical inconvenience of having every 9-11 year child fast for 12 hours, twice, to get poked with a needle, when the most likely outcome is that they’ll be told that they need to eat a healthy diet and exercise. Of more concern is the astute point raised by Newman et al that girls have higher cholesterol levels and are more likely to get labeled and treated, but paradoxically are at lower CVD risk. In regard to dietary interventions like the CHILD-1 diet, it is not clear to me why healthy eating patterns would not be recommended to all children and families, regardless of their lipid status. In regard to the safety of statins in children, I would argue that the evidence base is slim and likely biased. What is known about their efficacy in children is limited to their effects on surrogate markers. Although it is likely that long term use of statins will reduce CVD risk in children with hyperlipidemia, we have to be honest and recognize that changes in lipid levels and carotid intima-media thickness are not the same as reductions in CVD event rates. The chain of evidence is present, but the links are weak. Accordingly, we have scientific equipoise, not the scientific basis for a strong public health recommendation.
One good point for universal screening – previously raised by Marilyn Mann in a comment on Cardiobrief.org – is that after kids leave home, they often drop out of medical care for a time, so it is easier to identify them when young, even if they do not get treated. It is a fair point, but in my opinion, does not justify screening all children, to find the small number of kids with familial hypercholesterolemia (FH) who would not have been identified by targeted screening. However, this is a question that could be addressed, in part, by mathematical modeling. The guideline writers would have strengthened their case if they had presented an analysis of the number of new FH cases identified with universal screening, the number of cases of “dyslipidemia” identified, the number of true and false positives and negatives, as well as the costs and effectiveness of the screening program that they proposed. It would be a challenging and imperfect analysis, but one that should have been done before the guideline was approved, rather than being left to future researchers.
For the record, I have declined to have my kids screened, even though we are in a purportedly higher risk group (Ashkenazi Jews).
The Influence of Industry on the Universal Screening Debate
The debate about universal screening is a fair and important one, but the influence of industry interferes with our ability – indeed, our obligation – to honestly debate and discuss this important public health issue. It is amazing that every time the specter of conflict of interest is raised, doctors and researchers get pretty edgy. You can literally see the hairs rise on their backs. And of course, everyone is an expert on this issue and no one is biased. That is unfortunate, because a strong social science literature has taught us that everyone is biased. To illustrate this point, let’s focus on some of the guidelines writers’ responses.
The guideline writers’ contention that “medical treatment recommendations are based on multiple randomized trials of statin therapy in children with FH demonstrating acceptable safety and efficacy over periods up to 2 years” rings hollow. Almost all of those studies were sponsored and conducted by pharmaceutical companies, including several that have been investigated and even sanctioned for improper handling and reporting of data, including safety data. The studies had small sample sizes and were of short duration, and therefore tell us very little about long-term safety of statins in children and young adults. I am sure that the limitations of these studies would be easy fodder at any medicine or pediatrics resident journal club. But the guideline panel uses these studies as high level evidence to support their deeply held belief in statin safety and their desire to prevent CVD. Preventing CVD is laudable, but one must ask where their belief in long-term statin safety came from when the power of the evidence base to detect even common side effects in children and young adults, is limited and only of about 2 years duration. It likely came from repeated encounters with the pharmaceutical industry, which has inundated us with statin safety messages, as well as our own belief in what we do. These are unconscious, intellectual biases that we, as humans, all succumb too. They are even more insidious when an external influence – in this case the pharmaceutical industry – suggests them to us.
Even more dangerous to the academic mission and our societal obligation to have an open and honest debate is the effect of financial conflict of interest. Here the guideline writers reacted emotionally, rather than responding intellectually. In response to the concern about financial conflicts of interest, the guideline writers state: “To contest the integrity of panel members and their deliberations without evidence is unfair and uninformed.” But actually, it is not. It is their response that is uninformed. The guideline writers’ response is moralistic and defensive, rather than academic. I understand how people get defensive when the issue of financial conflict of interest is raised, but no one is impugning anyone in this debate or challenging their integrity for having a potential conflict of interest. All of these individuals are good, honest physicians and researchers, doing their best to come up with helpful public health guidelines to prevent CVD. In that regard, we all are on the same team. But when people have financial relationships, the data demonstrate that they engage in unintentional motivated reasoning – i.e., they become biased. They can’t help it. It is a by-product of being a human being. Humans are living, breathing, bias machines. We all try to manage our biases, but sometimes we can’t. The key point is that bias is unconscious and does not imply malfeasance or wrong-doing. We just can’t help it. And disclosure, although laudable, does not solve the problem of bias because the problem is not secrecy – it is power. Indeed, disclosure may even have the “perverse” effect of increasing bias. In this regard, a major problem with the pediatric lipid guidelines is that they did not follow best practices for managing potential conflicts of interest.
Here’s to an honest, intellectual debate on an important public health topic. Although I oppose universal screening, I am willing to discuss and debate it, ask for more evidence, and recognize its potential advantages and weaknesses. But I suggest we leave the pharmaceutical and device/testing industry out of it, to minimize (not eliminate) the biases and to increase the level of civility in our deliberations.
August 13th, 2012
Industry PR Efforts Influence Debate On Cholesterol Screening Guidelines For Children
Larry Husten, PHD
Note: This post is accompanied by a separate post by James Stein.
What role should industry play in discussions about guidelines, especially when the debate about those guidelines includes allegations that industry may have influenced the final product of the guidelines? Should a public relations agency that represents a company with a product that would be affected by a guideline offer journalists a chance to interview an expert who has views that might benefit the company?
Let me first set the stage. An important debate assumed public form last November following the publication in Pediatrics of new National Heart, Lung, and Blood Institute guidelines recommending universal cholesterol testing for children. The debate heated up earlier this year with two JAMA articles containing biting criticism of the guidelines, one of which was co-authored by a dissenting member of the guidelines committee. Now the controversy has flared yet again, with the recent appearance of two articles in Pediatrics, one attacking the guidelines and the other a defense of the guidelines by several members of the committee.
Before getting into the role of industry, I first want to emphasize that the scientific and public health issues involved in this debate are of the highest possible importance. Cardiovascular disease remains the number one killer in the world, and although efforts to reduce cardiovascular disease have achieved remarkable success in recent decades, the rising tide of obesity and diabetes threatens to roll back much of this progress and is reshaping (literally and figuratively) childhood and adolescence. So prevention of cardiovascular disease, which starts in childhood, is a major concern that deserves serious discussion.
An excellent example of the type of discussion we need is provided in an accompanying article by James Stein. His eloquent piece provides a thoughtful perspective and overview of the debate. I don’t have much to offer beyond what Stein writes, but in this piece I’d like to present a recent and highly relevant anecdote that might help illuminate the part of his discussion about the role of industry influence in this debate.
A few days after the publication of the Pediatrics papers, I received an email message from a public relations agency. Here it is (names and other identifying details redacted):
Hi Larry,
Last week the journal Pediatrics published a paper that argued current guidelines for cholesterol screening among children are too aggressive, sparking a debate that garnered multiple news headlines. However, an important factor was widely overlooked – a genetic disease that causes high cholesterol at a young age regardless of common risk factors like diet and exercise.
[Dr. XXX] was a member of the expert panel that developed the current testing recommendations of the National Heart, Lung, and Blood Institute (NHLBI). The guidelines, which were endorsed by the American Academy of Pediatrics, call for screening for all children ages 9 to 11 and screening for certain high-risk children ages 2 to 8.
Dr. [XXX] points to familial hypercholesterolemia (FH), a genetic disorder associated with elevated cholesterol and premature coronary artery disease, as a primary concern when considering the need to test cholesterol levels in children. The disease affects about 1 in every 500 people in the general population, and can be 2 to 5 times more common in specific ethnic groups like French Canadians and Ashkenazi Jews. FH is caused by genetic mutations that lead to abnormalities on the surface of liver cells responsible for clearing LDL (bad cholesterol) particles from the blood. As a result, cholesterol accumulates in the bloodstream beginning at an early age.
Dr. [XXX] is available for an interview to share his perspective on the current NHLBI guidelines and why he strongly supports screening for cholesterol levels in children. He can also outline the steps that families should take to review family history to identify an elevated risk of FH inheritance. Might you be interested in speaking with Dr. [XXX]? I am happy to answer any questions you may have and look forward to your response.
Many thanks,
[PR Person][PR Company]
After a very brief internet search, I learned that the PR company was affiliated with a pharmaceutical company that has placed high hopes on a cholesterol-lowering drug that is in late-stage development for use in familial hypercholesterolemia. When I asked the PR person about this relationship, he readily acknowledged the connection, writing:
I’m working with [FH Drug Company ] on an unbranded effort to raise awareness of familial hypercholesterolemia. An interview with Dr. [XXX] about the disease won’t cover the company or its products.
I then spoke with Dr. XXX for nearly 90 minutes and, indeed, he did not talk about FH Drug Company or its products, and he provided a passionate defense of the guidelines, which in some sense may be said to represent the summation or fruition of his career as a physician and researcher who treats children with lipid disorders. Dr. XXX does not receive money from FH Drug Company, but he acknowledged that he does receive financial support for some of his activities from the National Lipid Association (NLA), and that he is well aware that FH Drug Company is a major funding source for the NLA. (I wrote a series last year about the NLA and its relationships with industry.) He also talked about the difficulty of performing research in the field without the support of industry.
After the interview I asked the PR person to elaborate on his firm’s relationship with FH Drug Company. He wrote:
We have been working with [FH Drug Company] for several months in efforts to raise awareness of FH, which as you’re aware is not widely known and often goes undiagnosed. Dr. [XXX] was actively involved in developing the NHBLI guidelines and also has an expert understanding of FH. As the debate about the guidelines has continued, reporting often has not referenced the needs of people affected by FH and the disease’s impact on early screening guidance. [FH Drug Company] is supporting efforts to help more people to learn about FH in general and also to make sure that the distinct needs of people living with FH are represented in these discussions.
Readers who are not journalists may be surprised to learn that this incident is not at all unusual in the world of medical journalism. PR companies regularly offer up academic “experts” to journalists, and this is rarely an altruistic endeavor. (See this post for my discussion about a particularly egregious example of this practice.)
One key criticism of the Pediatrics guideline is that the final product may have been influenced, consciously or not, by the relationship of its authors with industry. Here is how Newman and colleagues describe this problem in their Pediatrics article:
The greater a guideline’s reliance on expert opinion, the more important it is to avoid even the appearance of conflict of interest. Yet the majority of panel members, including those responsible for drafting the lipid and lipoprotein chapter, disclosed an extensive assortment of financial relationships with companies making lipid-lowering drugs and lipid-testing instruments. Accepting money from industry constitutes a conflict of interest that is not ameliorated by disclosure. That so many panel members with conflicts of interest were selected to draft the pediatric lipid guidelines undermines the credibility of both the guidelines and the process through which they were produced.
It seems to me nothing short of bizarre that the PR company responded to the allegation of inappropriate industry influence with a perfect example of inappropriate industry influence. Frankly, when I discovered the initial connection between the PR company and FH Drug Company I was astounded. However, the blithe response of the PR representative and Dr. XXX would suggest that in the perception of these issues there is an enormous gulf over which it will be extremely difficult to build any sort of bridge.
In his piece, James Stein provides an excellent brief summary of the potential problems involving physicians who have conflicts of interest. What I want to add here is that through public relations activities, advocacy groups, and other related activities, companies extend their influence beyond their direct relationships to scientists and physicians and use these relationships to influence and shape the public discussion and perception of issues of importance to them. In my view, companies clearly have the right to express their views. However, when these views gain exposure and credence through outside “experts” through the support and subtle activities of public relations activities, we have moved out of the realm of simple free speech and into the arena of inappropriate commercial influence.
August 9th, 2012
Reports from JUPITER and Taiwan: Benefits of Statins Outweigh Risk for Diabetes
Larry Husten, PHD
Two new papers provide further evidence that statin use is associated with an increased risk for diabetes, but both studies also find that the benefits of statins still outweigh the risks.
In one report, published in the Lancet, Paul Ridker and colleagues analyze data from the JUPITER trial, which compared rosuvastatin to placebo in a primary-prevention population.
Among the 17,603 patients randomized in the trial, 11,508 had at least one major risk factor for developing diabetes. In this group, the primary endpoint (MI, stroke, hospitalization for unstable angina, revascularization, or CV death) was reduced by 39% in the statin group (hazard ratio 0·61, CI 0.47–0.79, p=0·0001). The authors calculated that in the statin group, 134 vascular events or deaths were avoided for every 54 new cases of diabetes. For the 6095 patients without a major risk factor for diabetes, the primary endpoint was reduced by 52% (HR 0·48, CI 0.33–0.68, p=0·0001). No increase in diabetes was observed. In this group, 86 vascular events or deaths were avoided.
During the JUPITER trial, 486 subjects developed diabetes (270 in the rosuvastatin group and 216 in the placebo group). The risk reduction in this group was consistent with the overall reduction observed in the trial.
“Our results show that in participants with and without diabetes risk, the absolute benefits of statin therapy are greater than the hazards of developing diabetes,” said Paul Ridker, in a press release issued by the Lancet. “We believe that most physicians and patients would regard heart attack, stroke and death to be more severe outcomes than the onset of diabetes, and so we hope that these results ease concern about the risks associated with statin therapy when these drugs are appropriately prescribed – in conjunction with improved diet, exercise and smoking cessation – to reduce patients’ risk of cardiovascular disease.”
The findings from JUPITER were echoed in a large observational study from Taiwan published in the Journal of the American College of Cardiology that compared 8412 people receiving statins with 33,648 matched controls. The Taiwan investigators found that although, over a median of 7.2 years, the rate of diabetes was significantly higher among statin users (2.4% vs. 2.1%, p<0.001), statins were associated with a significant reduction in cardiovascular events (HR 0.91, CI 0.84 to 0.99, p = 0.031).
August 9th, 2012
Overview of the New HRS/ACCF Pacemaker Guidelines
Edward J. Schloss, MD
Since the development of the first dual-chamber pacemakers in the 1980s, doctors have had the choice of using single- or dual-chamber devices in patients with traditional pacing indications. A number of pacemaker guideline consensus statements have been published over the years, but none has provided guidance on specific device types or pacing-mode selection.
The Heart Rhythm Society and American College of Cardiology Foundation recently published online the HRS/ACCF Expert Consensus Statement on Pacemaker Device and Mode Selection. The authors intend this to be a supplement to the 2008 pacemaker guidelinesand classify indications in similar fashion, ranging from class I (general agreement regarding benefit) to class III (not useful, or harmful). Biventricular pacing is not addressed in these documents, having been covered elsewhere .
The document is concise and clearly stated, and I would refer all those close to the field to the link above. Below, I will add my own brief summary and comments.
Sinus node dysfunction (SND) gets a clear endorsement for dual chamber (DDD) pacing with a class I indication, even in those without manifest AV conduction abnormalities. The authors still give a class I alternative for single-lead atrial (AAI) pacing, but only in patients with normal AV conduction. The recent DANPACE trial is cited showing reduced incidence of atrial fibrillation and need for reoperation in the patients with SND getting dual-chamber devices versus single-chamber atrial devices. Doctors have clearly embraced this indication, as single-chamber atrial pacing is rare, especially in the U.S.
Dual-chamber pacing in SND is also favored over single-chamber ventricular pacing (VVI), as it has been shown to reduce the risk for development of atrial fibrillation and the symptoms of pacemaker syndrome. Rate-responsive pacing is given a class IIa indication for patients with documented chronotropic incompetence. This may be an academic distinction alone, as all modern pacemakers now have rate-responsive capabilities.
In AV block, dual chamber pacemakers also get a class I indication. Single-chamber ventricular pacing is considered an acceptable alternative in sedentary patients or in patients for whom technical issues make atrial lead placement difficult or impossible. Patients with persistent or permanent atrial fibrillation are also indicated for single-chamber ventricular pacers unless efforts are being made to restore sinus rhythm. Single-lead VDD pacing in those with intact sinus node function (e.g., a young patient with congenital AV block) gets a class IIa indication.
Fewer data were available to support consensus recommendations on some of the less common syndromes with pacing indications, and most did not rise to the level of class I.
– In carotid sinus hypersensitivity, both DDD and VVI pacing get class IIa recommendations. AAI pacing is not recommended.
– Neurocardiogenic syncope with associated bradycardia gets a class IIa recommendation for dual-chamber pacing. AAI is not recommended. The evidence base cited is sparse for this indication, but it does not include the favorable ISSUE-3 trial reported at this year’s ACC meeting.
– Symptomatic or high-risk long-QT syndrome is a class I indication for DDD or AAI pacing. The authors also acknowledge a role for ICD implantation in this population.
– Hypertrophic cardiomyopathy with significant LV outflow obstruction was given a class IIa indication for DDD pacing.
Although dual-chamber pacers have higher up-front costs, the authors suggest that these savings must be weighed against the difficulty of upgrading single- to dual-chamber pacing systems if the need arises later. Studies have shown up to 45% incidence of complications with upgrade procedures. Cost-effectiveness data for dual-chamber devices, taking into account the reduction in atrial fibrillation and need for reoperation, has also been shown to be favorable.
Little controversy will likely arise from these guidelines. Device and mode selection for traditional pacemakers has been worked out in principle for years, and these guidelines generally reflect common current practice. Not covered — but very open to question — is the decision process surrounding device and mode selection in the ICD population. Recent data showing high popularity of dual-chamber ICDs despite increased complications and periprocedural mortality suggests guidance in this area would be welcome.
August 9th, 2012
Go For a Walk: Can Six-Minute-Walk Distance Predict CV Events?
Alexis L Beatty, MD and John Ryan, MD
In this post, Alexis Beatty discusses her Archives of Internal Medicine study, which found that the Six Minute Walk Test (6MWT) improves risk prediction in people with stable coronary heart disease (CHD). CardioExchange’s John Ryan follows up with questions for Beatty about the test.
We have a number of simple tools for predicting risk of a first CHD event. However, our arsenal of tools for predicting risk of secondary events in patients with stable CHD is not as well-stocked. In our recent study we investigated whether the 6MWT — a simple test of functional exercise capacity measuring the distance a person can walk in six minutes — could predict cardiovascular events in a cohort of 556 outpatients with stable CHD enrolled in the Heart and Soul Study, a prospective cohort study at the San Francisco Veterans Affairs Medical Center and University of California, San Francisco.
Those who walked the shortest distance in six minutes (87–419 m) were significantly more likely to have a cardiovascular event (myocardial infarction, heart failure, or death) than those who walked the longest distance in six minutes (544–837 m; 62% vs. 22%). When we compared the improvement in risk prediction with the 6MWT to the improvement in risk prediction with Treadmill Exercise Capacity, we found that the tests were comparable. Thus, the 6MWT may be a simple, inexpensive, and useful tool for determining prognosis in outpatients with stable CHD.
While the results may not be immediately generalizable to all populations (our study had mostly males and we only performed the 6MWT in participants who thought they could walk for six minutes without symptoms), they suggest the potential for the 6MWT to be employed in clinical practice. Also, it would be interesting to see if improving the distance achieved during the 6MWT over time would result in better outcomes.
Ryan: What limited the patients from walking further during their 6MWT test? If they developed fatigue or dyspnea, how confident are we that these symptoms were not an anginal equivalent in this population with stable CHD?
Beatty: Participants who did not think that they could walk for six minutes without having symptoms such as dyspnea or chest pain were not administered the 6MWT in our study. Few patients were limited by chest pain, shortness of breath, or musculoskeletal pain. It is possible that symptoms experienced with a walking test could be an anginal equivalent.
Ryan: Under what circumstances would you recommend a patient with stable CHD be referred for the 6MWT instead of standard stress testing?
Beatty: If the goal is to determine prognosis or functional exercise capacity in a stable patient, then the 6MWT may be preferrable to standard stress testing. If the goal is to diagnose ischemia, standard stress testing would be appropriate and the 6MWT would not be recommended.
Would you perform the 6MWT in your outpatients with stable CHD?
August 8th, 2012
Selections from Richard Lehman’s Literature Review: August 8th
Richard Lehman, BM, BCh, MRCGP
CardioExchange is pleased to reprint selections from Dr. Richard Lehman’s weekly journal review blog at BMJ.com. Selected summaries are relevant to our audience, but we encourage members to engage with the entire blog.
JAMA 1 Aug 2012 Vol 308
Heart Failure and Depression (pg. 465): Living with heart failure is a miserable business, and about 40% of patients with this label are clinically depressed. This is due to a complex mix of factors: the biochemical “feel-bad” factors alone are too complex to list here, and they come from every system in the body, not just the left ventricle. Small wonder that depression in heart failure is associated with physical deconditioning and increased mortality. This study recruited 2322 subjects with systolic heart failure and depression from the USA, Canada and France and randomised them to an exercise programme or guideline-based care. At a median follow-up of 30 months, two-thirds of both groups were dead – these people really did have failing hearts. Survivors from the exercise group had slightly lower depression scores. The authors admit that this may be of little importance in the greater scheme of things. I would suggest that this study is one more illustration of the fact that people with heart failure and depression are in the final trajectory of their lives, and badly need the supportive and palliative care that so few of them can currently access.
Endoscopic vs. Open Vein-Graft Harvesting in Patients Undergoing CABG (pg. 475): The heyday of coronary artery bypass grafting is over, but I don’t see any end to the bickering over detail: off-pump or on-pump, arteries or veins, or if veins, harvested by endoscope or through a long incision. This careful registry search shows that on the last point, honours appear to be equal, in terms of mortality and revascularization, and using the endoscope leads to fewer immediate wound complications at the harvesting site.
Lancet 4 Aug 2012 Vol 380
Linagliptin vs. Glimepiride in Patients with Type-2 Diabetes (pg. 475): Like everybody else, I would really welcome the arrival of lots of new drugs to treat type 2 diabetes. I’m easily carried away by the optimism that surrounds the introduction of each new drug class, such as the gliptins or dipeptidyl peptidase-4 inhibitors. For all we know, these blood sugar lowering agents may be a real advance on the sulfonylureas we currently tend to use as second-line treatment. This trial comparing linagliptin with glimepiride shows that it lowers glucose by about the same amount, and with less risk of hypoglycaemia. But what of its long-term safety? And what effect does it have on the vascular events which are the main reason for treating diabetes? This trial was not designed to tell us about these, and we will simply have to wait for longer and bigger trials. In the meantime, each time you use a drug in this class, you are carrying out an experiment, and you have an ethical responsibility to tell your patient that you don’t know whether your treatment is going to be either safe or beneficial.
BMJ 4 Aug 2012 Vol 345
Weight Gain with Smoking Cessation: One of the biggest perceived barriers to smoking cessation is the fact that most people gain weight after quitting. This meta-analysis offers no comfort at all: it shows that the mean weight gain is 4-5kg and most of it happens within 3 months. Most people find it difficult enough to overcome nicotine addiction and the thought of gaining 10lb in a few weeks is hardly encouraging. It would be useful now if somebody could do a further meta-analysis to see if particular smoking cessation treatments can prevent some of this weight gain.
ACE Inhibitors and Pneumonia Risk: Inhibitors of angiotensin converting enzyme are also inhibitors of bradykin breakdown, so there is no such thing as an ACE inhibitor that does not increase coughing, especially during episodes of respiratory infection. Many people give up taking ACE inhibitors for this reason, but those who persevere are rewarded by a reduction in pneumonia, as demonstrated in this Portuguese systematic review. This effect is largest in observational studies carried out in Asia, and it is not seen with angiotensin receptor blockers, which have no effect on bradykinin breakdown.
Speech Therapy After Stroke: Speech therapy following stroke has no effect on speech recovery. The clear result of this Manchester trial will come as a blow not just to speech therapists but to many stroke sufferers and their families. Speech therapy is really supportive therapy, a token that society cares and is trying its best. The evidence here shows that you could take it away with no effect on speech, but that would leave people feeling that nobody was doing anything. And we disparage this kind of “futile” care at our peril: a lot of what we do as doctors falls in the same category. The difficult trick is to preserve this ability while remaining honest with ourselves and our patients.
August 8th, 2012
Risks and Benefits of Pediatric VAD Explored
Larry Husten, PHD
Few options besides extracorporeal membrane oxygenation (ECMO) have been available for children with systolic heart failure awaiting transplantation. Now, a report by Charles Fraser, Jr., and colleagues published in the New England Journal of Medicine provides important new information about a ventricular assist device (VAD) designed for children.
Trial investigators implanted 48 patients with the Excor Pediatric VAD (Berlin Heart) and compared them with matched historical controls who had received ECMO. The VAD group comprised two 24-patient cohorts based on body-surface area. Survival was dramatically and significantly longer in both VAD cohorts:
- Cohort 1 (body surface area, <0.7 m2): the median survival time in the VAD group had not yet been reached at 174 days, while the median survival time with ECMO was 13 days (p<0.001)
- Cohort 2 (0.7 to <1.5 m2): median survival: 114 days with VAD versus 10 days with ECMO (p<0.001)
However, VAD treatment was associated with clinically significant adverse events. Major bleeding occurred in 42% of cohort 1 patients and 50% of cohort 2 patients, infection in 63% and 50%, and stroke occurred in 29% of patients in each cohort.
In an accompanying editorial, Linda Addonizio observes that the development of pediatric VADs has been markedly slower than the development of adult VADs, although “the potential number of years of life saved for each person is much greater for children.” However, because of the high rate of neurological complications, she urges caution before “extending the current practice in adults of early implementation of ventricular assist devices to children.” VADs, she writes, “should remain, at present, a last resort in small children.”
August 8th, 2012
Feds Turn Corner in ICD Investigation, Hospital Liability Divided into Categories
wpengine
Editor’s note: The following article is reprinted with permission from Report on Medicare Compliance, an independent publication not affiliated with hospitals, government agencies, consultants, or associations and published by Atlantic Information Services, Inc.
The Department of Justice is apparently about to take a big step forward in its national false claims investigation of Medicare billing for implantable cardiac defibrillator (ICD) procedures. After a year of debating the medical-necessity parameters of ICD implants, DOJ now has a blueprint for determining hospital liability, according to attorneys familiar with the case. Some ICD cases will be home free, while others will be the subject of repayment plus interest or triple damages, they say.
“There has been a breakthrough,” one attorney says.
As a result, DOJ will soon send letters to hospitals with instructions for resolving their potential ICD overpayments. Hospitals will be asked to self-audit ICD procedures using an audit tool the federal government developed in collaboration with defense counsel and Navigant Consulting, attorneys say. After the audits are completed, hospitals will report back to DOJ, which will spot check their findings. Then settlement talks presumably will begin, the attorneys say.
“They want to move forward and close these cases that have been pending for close to two years,” says another attorney. The U.S. Attorney’s Office for the Southern District of Florida, which is spearheading the case, had no comment.
The investigation of ICDs, which are small electronic devices that shock the heart back to a normal rhythm, focuses on hospital claims that ran afoul of Medicare’s national coverage decision (NCD 20.4). Initially, DOJ took the position that noncompliant billing for ICD implantation is within the realm of the False Claims Act, but it paused to consider that perhaps medical necessity in this area is not always black and white. “There will be cases that literally or technically are outside of the NCD but the government will not be demanding a repayment because there are just some scenarios that clearly were not contemplated by the authors of the NCD,” one attorney says.
The NCD for ICDs describes nine categories — “covered indications” — that trigger Medicare payment (RMC 10/31/11, p. 1). They are divided into indications for primary prevention, which means the patient did not experience prior episodes of an irregular heartbeat but is still at elevated risk for sudden death due to cardiac arrest, and secondary prevention, which means the patient had prior episodes of an irregular heartbeat.
Only the indications for primary prevention — three through nine — have “timing requirements.” Medicare won’t pay for a patient’s ICD implant within 40 days of an acute myocardial infarction (MI) or within three months of a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA). For example, Medicare covers ICDs for patients with non-ischemic dilated cardiomyopathy and for patients with coronary artery disease with a documented prior MI, as long as acute MI didn’t occur in the previous 40 days. The idea is to first give patients time to recover from the heart attack to determine whether the patient really is at elevated risk for cardiac arrest.
Hospitals May Not Be as Vulnerable
If hospitals billed Medicare for ICD procedures, they may be at risk in the national false claims enforcement action. But they may not take as big a hit as was feared when DOJ first sent out subpoenas and civil investigative demands, lawyers say. “There are some different categories where the hospitals and doctors have good things to say about the medical necessity of the decision to implant. And the government has now acknowledged the decision to implant and no demand for money will be made in those cases,” one attorney says.
Some categories of ICD cases that are not NCD compliant won’t face any repayment, one attorney says. For example, a patient may need a pacemaker or a pacemaker replacement or the surgeon recommends a pacemaker ICD combination. Although the cardiac patient may clearly be entitled to the pacemaker, a recent acute myocardial infarction places him outside the reach of the ICD because of the timing requirement. “Some scenarios were clearly not contemplated by the authors of the NCD,” he says. For that reason, DOJ is expected to let these cases off the hook, the attorney says.
Timing Requirement Can Be a Problem
But it doesn’t look like the government will go easy when hospitals billed in violation of the timing requirement in other circumstances, the attorney says. For example, some patients are “previously qualified.” They are entitled to ICDs under the NCD’s primary indicators but subsequently have an acute MI, CABG or PTCA while deciding whether to proceed or waiting to schedule surgery. That essentially restarts the clock on Medicare coverage for their ICD surgery — 40 days from their MI or 90 days from their CABG/ PTCA. “There had been hope that DOJ would include that as a category with zero damages, but rumor is those cases will not be included in the zero-damages category,” the attorney says. “They will be treated in a category for which the government will seek some form of payment.”
The attorney doesn’t think that makes much sense. If patients were qualified on Jan. 1 but had an intervening event, such as an acute MI, there’s no reason to think they will be in better shape during the 40-day waiting period.
ICDs Also a Focus of Compliance Review
ICD noncompliance also recently made its first appearance in a Medicare compliance review, although it was the outpatient version and the DOJ investigation targets inpatient ICDs. Still, the NCD applies, and the HHS Office of Inspector General determined that Tampa General Hospital incorrectly billed Medicare for one outpatient surgery “because the beneficiary had a PTCA within 3 months of the ICD implantation,” OIG stated, resulting in a $25,583 overpayment.
Tampa General Hospital has edits in place to ensure ICD claims are screened before submission. That job falls to the Medical Bill Audit Department, which consists primarily of clinicians, say Ron Peterson, chief compliance officer, and Stephen Harris, director of reimbursement. “The edit is like a marker. It identifies these cases so they are reviewed,” Harris tells RMC. “We still have to write them off from time to time because they don’t meet criteria.” At the same time, the hospital and its physicians are taking more time to evaluate the medical necessity of the procedure before it’s performed, Harris says. The ICD investigation has “raised the bar on the criteria before a device can be implanted.” And for its part, the government has become more aware that this is not black and white. “Treatment of patients is so dynamic and doesn’t always fit into a regulation. You will see this evolve.”
Generally, to avoid claims denials or false claims for ICDs and similar procedures, it’s a good idea for hospitals to study relevant NCD and local coverage decisions, the attorney says. “There is a large but not infinite number of NCDs in the NCD manual, and it would be a good move for hospitals to figure out which apply to them and make sure they are trained and knowledgeable about them,” the attorney says.
If hospitals decide to bill for an ICD or other procedure outside the scope of the NCD, “do it in a transparent way that puts the Medicare administrative contractor on full notice,” he says. “There are some good arguments that something outside the NCD is still covered by Medicare and you have to bill it to preserve your appeal argument, but you have to do it in a transparent way.” Or don’t charge for it. He emphasizes that the NCD applies to professional services as well, so if the procedure isn’t covered, physicians can’t bill for it either.
August 7th, 2012
Survey Finds Significant Drop in Cholesterol Levels in Youths
Larry Husten, PHD
New data from the National Health and Nutrition Examination Survey (NHANES), published in JAMA, show significant and perhaps surprising improvements over the last 20 years in the lipid profile of youths aged 6-19 years. Among the key lipid parameters measured by the survey from 1988-1994 to 2007-2010:
- Total cholesterol decreased from 165 mg/dL to 160 mg/dL (p<0.001)
- Prevalence of elevated total cholesterol declined from 11.3% to 8.1% (p<0.002)
- HDL increased from 50.5 mg/dL to 52.2 mg/dL (p<0.001)
- Non-HDL decreased from 115 mg/dL to 107 mg/dL (p<0.001)
“Generally,” the authors report, “the sex-, age-, and race/ethnicity-specific trends for TC, HDL-C, and non– HDL-C were similar in direction to the overall trends and consistent with a favorable trend, although for each group, the magnitude was not the same and the trend was not always significant.”
The change over time in lipids in youths was paralleled by similar changes in adults, according to the investigators. They also note that the improvement in lipids occurred “despite an increase in obesity prevalence during the study period.”
The changes recorded in the survey are “clinically meaningful” and a “cause for optimism,” writes Sarah de Ferranti in an accompanying editorial. “But,” she asks, in the face of the increase in obesity, the decline in exercise, and other adverse trends, “why would childhood cholesterol improve?” She briefly considers several possible explanations for the improvement, including improved interventions and healthier lifestyles, but then finds “a more plausible explanation” to be “dietary shifts at a population level”:
Dietary intake of fat has declined over the past several decades and some studies suggest substitution of carbohydrates for dietary fat, particularly poor quality carbohydrates, might both promote obesity and explain some of the lipid changes reported [here].
Another less concerning cause may be the reduction in the use of trans fats over the study period, she writes.
August 7th, 2012
NY Times: HCA Concealed Significant Problems at Lucrative Cardiac Centers
Larry Husten, PHD
Despite numerous internal reviews that turned up a widespread pattern of unnecessary cardiology procedures being performed at many of its hospitals, the giant HCA corporation did little to rein in the problem or to inform regulators, payers, or patients about it, according to an investigative report in the New York Times by Reed Abelson and Julie Creswell. The story was published less than a day after the company disclosed that it was being investigated by the U.S. Attorney’s office in Miami.
The Times recounts numerous instances in which the company discovered a problem at one of its hospitals but then acted to conceal the problem or to prevent its recurrence at other hospitals. In one case, a nurse’s contract was not renewed after he reported to the company that unnecessary procedures were being performed at Lawnwood Regional Medical Center in Fort Pierce, Florida, although an internal HCA investigation had substantiated the allegations.
The Times gained access to internal HCA reviews which found that, from 2002 until 2010, “some cardiologists at several of its hospitals in Florida were unable to justify many of the procedures they were performing” and, “in some cases, the doctors made misleading statements in medical records that made it appear the procedures were necessary.”
At Lawnwood, about half of cardiac catheterizations (roughly 1200) appeared to have been performed on patients “without significant heart disease,” the Times reports. HCA responded that the Longwood numbers were consistent with the national averages. (The Times doesn’t fully explain the numbers, but it should be noted that a study published in the New England Journal of Medicine from the National Cardiovascular Data Registry [NCDR] reported a low diagnostic yield for diagnostic coronary angiography.)
At the Regional Medical Center Bayonet Point, a 44-year-old man with chest pain “suffered a punctured blood vessel and a near-fatal irregular heartbeat after a doctor performed a procedure that an outside expert later suggested might have been unnecessary.” In another case, “a woman with no significant heart disease went into cardiac arrest after a vessel was cut when a Bayonet Point cardiologist inserted a stent.”
An examination of HCA internal documents “reveals that rather than asking whether patients had been harmed or whether regulators needed to be contacted, hospital officials asked for information on how the physicians’ activities affected the hospitals’ bottom line,” the Times reports.
In another episode from 2003, a confidential memo from an HCA cardiac oversight team found that patients at Bayonet Point “were treated for multiple lesions, or blockages, even when ‘the second lesion (or third) did not appear to have significant disease.’ The team went on to note ‘several cases’ in which patients were treated even though their arteries did not have significant blockages.”
A subsequent review by an external company concluded that 43% of angioplasty procedures at Bayonet Point “were outside reasonable and expected medical practice.” In some cases, blockages that had been recorded as 80-90% were later determined by a “more scientific analysis” to have ranged from 33-53%.
Although the hospital suspended nine physicians after the report, HCA “took steps to withhold details of its conclusions to the media and others, according to internal communications.” The hospital CEO wrote to other HCA executives: “Clearly, we have protected ourselves under the peer review umbrella and have released very little information.”
An outside review found that one cardiologist who worked in the Lawnwood cath lab, Dr. Prasad Chalasani, had been found to be “too quick to perform catheterizations, often without first doing the stress tests necessary to determine whether a patient needed the invasive and costly test.” Nevertheless, he was highlighted in the hospital’s business plan “as being the most profitable doctor at the facility. ‘Our leading EBDITA MD,’ the plan described him.” (EBDITDA is a measure of corporate earnings, the Times notes.)
