Harm Outweighs Benefit When Cardiac Tests Are Marketed Directly to Consumers

Lots of attention has been focused on how over-testing, especially of the “worried well” contributes to high health care costs. To date, much of the focus has been on Medicare which spends a fortune each year on unneeded tests with no proven benefit.

Doctors, hospitals, demanding patients and defensive medicine have all been implicated in contributing to this glut of over-testing and treatment. But there’s another culprit that so far has avoided the scrutiny of government regulators. These are the stand-alone cardiac and similar health-related screening centers that employ heavy-handed consumer marketing techniques on the internet and through telemarketers; in some cases sending mobile screening units to church-sponsored and community events to help drum up business. 

Cardiac screening tests—including a CT scan for detecting the location and extent of calcified plaque in the coronary arteries—are meant to alert seemingly healthy people to the fact that they either have heart disease or are likely to develop it in the next few years. Patients don’t need a referral from a doctor to undergo cardiac testing at these centers and tests are not covered by insurance. The centers, which use direct-to-consumer (DTC) marketing, are not regulated by the Food and Drug Administration and have no mandate to refer patients with positive findings to a physician for follow-up care.

But with so many false positives and inconclusive results, many patients who do elect to have these tests end up undergoing a “cascade” of further interventions that are expensive (and are often covered by Medicare or private insurance). For example, a buildup of calcium in an asymptomatic patient’s artery might be detected yet would never have led to heart disease. Still, that patient may end up having such invasive treatments as cardiac catheterization or balloon angioplasty or be put on a statin or other medication for the rest of his life.

According to the U.S. Preventive Services Task Force (USPSTF), there is no evidence that routine cardiac calcium screening and other cardiac tests (electrocardiography, treadmill tests and carotid artery scans, for example) in otherwise healthy people will improve their health outcomes. In fact, the task force gave these screening tests a Grade D (not recommended) rating. Their reasoning is that because false-positive test results lead to unnecessary invasive procedures, over-treatment, and inappropriate labeling of disease, the potential harms of routine screening for heart disease actually exceeds the potential benefits. The task force was unable to recommend these tests even for adults at risk of coronary artery disease (but again, with no symptoms)—giving them a Grade I (insufficient evidence to make a recommendation) rating.

But this absence of benefit—and potential for harm—along with the fact that patients must pay for cardiac screening tests out of their own pocket hasn’t stopped the tests from being heavily marketed to consumers.

In fact, direct-to-consumer advertising for these tests makes the ubiquitous TV ads for Cialis featuring a couple relaxing outside in matching old-fashioned bath tubs seem refreshingly subtle. In a recent investigation by ProPublica that ran in the Las Vegas Sun, journalist Marshall Allen writes of receiving a telemarketing call offering “free heart scans for me and my wife, an $800 value, from a company called Heart Check America.” Allen and his wife ended up three weeks later at the company’s Las Vegas center getting a pitch from a salesman named Tom that included “an ominous PowerPoint presentation” and story after story of famous athletes and prominent people like newsman Tim Russert who “dropped dead of heart attacks” with no warning.

“After 45 minutes, Tom got down to business,” writes Allen. “He pulled out a price sheet and urged us to go beyond the free scans and upgrade to a 10-year contract for annual imaging services, including heart, lung, bone-density and other scans. If we signed up immediately, the contract — usually $7,995 — could be ours for just $2,995 plus $199 in annual dues. Financing was available on the spot.”

Allen continues; “In the past two years, Heart Check America has made similar pitches to tens of thousands of Americans in five states, bringing in about $30 million in revenue, according to its manager, David Haddad.”

But there have also been scores of complaints filed against the company—ranging from the high-pressure sales tactics they employ to lack of medical supervision and exposing patients to excess radiation. (The Las Vegas Heart Check center that Allen visited was recently closed, as was one in Denver after scrutiny from state regulators.)

According to the ProPublica piece, “Doctors have lashed into the company for marketing scans to those who most likely do not need them — people under 40 who don’t smoke, aren’t overweight, and have no family history or symptoms of heart disease.”

Dr. H. Gilbert Welch, a Dartmouth Medical School professor and author of “Over-Diagnosed” who is a critic of unnecessary diagnostic and screening tests told Allen that “scans can result in false positives, leading to unnecessary treatments that are invasive and risky…‘The assumption they’d like you to make is that this could only help you,’ Welch said of Heart Check America. ‘But that’s not right. It could hurt you.’”

A recent commentary in the Journal of the American Medical Association by Kimberly M. Lovett and Bryan A. Liang highlights the dangers and inappropriateness of DTC advertising for screening tests and points out the lack of oversight of this industry. The authors give the example of Lifeline Screening, a company that sends mobile units to churches, senior centers, health fairs and other community locations and boasts on its website, “6 million health screenings since 1993”.

The company “offers an online 8-question carotid artery stenosis (CAS) risk assessment; if any question is answered as yes, the next Webpage informs consumers that they are at risk and should consider screening. If all questions are answered no, the next page states, ‘Good news—your responses indicate that you are currently not at high risk for carotid artery disease. But remember that many people with this condition do not experience symptoms, so you may want to consider being screened anyway.’”

Lovett and Liang write that “because cardiac disease is a leading cause of death, DTC cardiac testing has tremendous potential reach.” Yet, they continue; “Despite these risks, there is no mandate on DTC cardiac testing companies to provide or coordinate patient access to follow-up care—placing uninsured and underinsured patients at particularly high risk because a positive result may lead to excessive concern without follow-up care or significant financial burden seeking care likely to yield no mortality benefit and even harm. DTC cardiac testing also induces inappropriate demand and wasteful use of insured care. Patients may seek follow-up care (covered by insurers) for positive results of questionable testing.”

The JAMA authors add, “Patients targeted by DTC advertising may also solicit physicians to order unwarranted testing hoping to save out-of pocket costs.”

The fear mongering and potential for unneeded interventions is bad enough, but there is evidence that cardiac scans also expose the “worried well” to excess radiation. Maryann Napoli, founder of the Center for Medical Consumers wrote in 2009 about the alarming three-fold increase in number of cardiac scanning centers in the U.S. and resulting rise in number of heart scans performed on symptomless people. “The American Heart Association, not known for warning the public about the negative aspects of medical care, acknowledged recently that the amount of radiation from a heart scan is equivalent to 600 chest x-rays,” writes Napoli.

For-profit screening companies like Heart Check and Lifeline are not the only ones pedaling CT scans and similar tests to the “worried well.” Hospitals are seeing the benefit in offering such screening too. The Cedars-Sinai Medical Center in Los Angeles sells gift certificates for $300 that you can buy to “Give heart screening to someone you love.” The hospital’s website elaborates; “A coronary calcium scan can be a good first step towards ensuring a healthy heart. What better gift could you give to someone you love?” Since a doctor’s referral is not required for the coronary calcium scan and it isn’t covered by insurance, the hospital seems to be suggesting this gift could be given to friends and family much like a certificate for a massage or facial. I’m sure I’m not alone in hoping that my loved ones choose to gift me with the massage rather than a cardiac scan …

The newest targets for DTC-marketing of cardiac testing are nervous parents of teen athletes. In recent years the media has focused on the high-profile cases of several high school athletes whose hearts stopped while they engaged in sports like football or basketball. This has led to calls from some parent advocates and doctors for mass electrocardiogram (ECG) testing to screen every youth athlete for potential heart problems.

On the website of “Teen Screen,” for example, (not to be confused with the test for depression and suicidal behavior of the same name that was developed at Columbia University), hospitals and other organizations are encouraged to offer free ECGs for young athletes to protect against the possibility that they might be at risk for sudden death. Here is text taken directly from this site that highlights how hospitals might benefit from offering this service:

“Why hold a cardiac screening program?
Is [sic] an excellent way to capture an untapped market with potential for high media exposure. Cardiac screening programs serve as a community-driven, mission focused and revenue enhancing marketing tactic for hospitals. Preventative cardiac screenings enhance hospital recognition and may increase new patient referral volume and generate downstream revenue. The screenings provide an excellent opportunity to introduce their facility and services to their community all while providing peace of mind to young people and their parents.”

The truth is that the benefit (other than increasing a hospital’s “patient referral volume” or generating “downstream revenue) of routine ECG screening for youth athletes is highly questionable. The American Heart Association does not recommend it because the test is imperfect, and according to USA Today, many cardiologists counsel against including an ECG in every pre-season physical because it “doesn’t catch every damaged heart and it sometimes flags hearts as potentially defective when they are perfectly healthy but are enlarged because of rigorous training… The downside to misidentifying healthy hearts as damaged, they say, is that kids may unnecessarily be encouraged to give up the sports they love.”

That would be unfortunate. It’s not completely clear how many teen athletes die from sudden cardiac arrest, but the USA Today story reports that data collected by the National Center for Catastrophic Sport Injury Research suggests that 15 high school athletes die each year due to heart-related problems. There are tens of millions of kids who participate in competitive sports. “To prevent one death in the U.S., where there’s a lower rate of inherited heart conditions that lead to sudden cardiac arrest, you’d have to stop almost 2,000 kids from playing sports,” Dr. Kevin Shannon, director of the pediatric cardiac arrhythmia program at the University of California, Los Angeles told USA Today.

It will be interesting to see how long it takes before for-profit testing centers start directing the hard sell to parents for teen cardiac screening. It’s already happening in the non-profit hospital realm. This October, for example, Legacy Health, operator of several hospitals and medical centers in the Pacific Northwest is offering “Teen Athlete Cardiac Screening” at the Memorial Coliseum in Portland for a $10 registration fee. Doctors and nurses working the event will be volunteering their time—but new patients and new business for the health system are undoubtedly on the minds of the organizers.

Beyond the teen controversy though, the JAMA authors have identified perhaps the most serious problem with the entire cardiac screening industry: the complete lack of regulatory oversight that allows these centers to test the “worried well” and basically create a whole new population of potential “patients” and consumers of health care.

Lovett and Liang are right on target when they call for the FDA to get involved in regulating the cardiac testing industry by:

•    Ensuring that companies offering direct-to-consumer cardiac testing disclose evidence-backed risks and benefits in their advertising.
•    Requiring promotional materials to provide links to relevant recommendations about cardiac tests from the Preventive Services Task Force
•    Making sure that interpretations of testing results are posted on company websites in such a way that they are easily understood by non-clinicians. Individual test results should also be presented clearly and in language aimed at the layperson.
•    Ensuring that testing companies provide counseling and consultation with a “qualified professional” before any testing takes place to guarantee that patients are making an “evidence-based informed consent.”
•    Requiring that patients have results provided to them by a qualified professional and should be given referrals to independent specialists for follow-up treatment if necessary.
•    Finally, companies should be required to inform consumers that they may report adverse events, including the quality of testing, safety concerns and inappropriate counseling to the FDA’s Medwatch database—a clearinghouse for collection of adverse medical events.

Over-testing has been identified as a major source of wasteful health care spending. For now, consumers have been allowed to spend their own money on tests that have been proven to serve no benefit and screening centers have eagerly courted them. Perhaps the rationale was that since the government or private insurers weren’t paying for it than what was the harm?

But it is becoming clear that consumer-initiated cardiac screening is driving up health care costs. By promoting additional invasive procedures and over-treatment, testing can lead to more harm than good. As we move toward implementation of health reform, we are asking patients to become more involved in making choices about care—especially when it comes to understanding costs and benefits of tests and treatments. But in order to do that we have to make sure they have access to evidence-based and easily understandable information. There is no place in this picture for the misleading and in some cases, blatantly false marketing that has increasingly been the strategy of testing centers that market their screening services directly to consumers.

3 thoughts on “Harm Outweighs Benefit When Cardiac Tests Are Marketed Directly to Consumers

  1. Very interesting article about how health care cost is drive up. This is analogus to drug companies directly marketing prescrition drugs to consumer’s. This leads to much wasted money on advertising to the tune of billions of dollars. Which could be better spent on R&D. Also, not to mention the added pressure it puts on physicians to give into patient demands for drugs they have no idea about other then what the commercial tells them.