Texas Heart Attack Prevention Legislation 'Premature,' Expert Says

Shelley Wood

March 01, 2011

February 28, 2011 (Dallas, Texas) — The quiet passage of 2009's Texas Heart Attack Prevention Bill will have ramifications that will "ring loudly" for public health, predicts a Commentary published in the Archives of Internal Medicine this week [1].

As reported in-depth by heartwire , the bill, known as HB 1290, grew out of a bold, unprecedented proposal from the Society for Heart Attack Prevention and Education (SHAPE, a group with no ties to either of the main cardiology professional societies) and mandates insurance coverage at regular intervals for coronary artery calcium (CAC) scanning and carotid ultrasound in the state of Texas. A new bill modeled on the Texas legislation is also poised for consideration in Florida in the coming weeks.

Writing in Archives, Dr Amit Khera (University of Texas Southwestern Medical Center, Dallas) suggests that while some of these tests may be appropriate for specific patients, support for their use at a legislative level goes far above and beyond what existing evidence supports.

He points out that there has been no published assessment of what it would cost, should the approximately 2.4 million people now eligible for coverage of these tests get screened. With $200 reimbursed for the test, the one-time cost would be $480 million, increasing if insured citizens opt to repeat the test at the five-year intervals specified in the bill.

Khera, in an interview with heartwire , acknowledged that these were "back-of-the-envelope calculations," but that even if his numbers are off by 100 000 potential patients, the dollar values are still in the millions.

"I'm not against this technology--I use it myself," he said. "But when you go from an individual doctor and a patient making a decision about a test to a statement like 'we should apply this to an entire population, and the evidence is so strong that we need a law,' I think then you need a much higher level of evidence and a more detailed look at all the ramifications."

Who, What, and Why?

At the heart of the controversy over the bill's passing is the fact that neither screening test has been proven in adequately powered trials to lead to diagnoses or preventive measures that translate into reduced adverse cardiovascular events. There is also no real consensus as to which patients might benefit from screening, what level of baseline risk would warrant further screening, and what steps should be taken as a result of any given finding.

According to Khera's calculations, looking at CAC screening alone, approximately 285 000 individuals in Texas who would be eligible for insurance coverage of screening based on criteria set out in the bill would be found to have calcium scores over 400.

Many of these people would already have another indication for taking statin therapy, he writes.

What's more, a one-time screen could be expected to result in 190 new cancers and find 190 000 incidental findings of "minimal consequence" that would inevitably be followed with further, possibly unnecessary tests, Khera notes.

"Ambiguity regarding the appropriate implementation of the tests, absence of randomized trial data, and lack of involvement of a broad group of stakeholders in developing the legislation all suggest that enactment of this bill was premature."

An editor's note by Archives editor Dr Rita Redberg accompanying Khera's commentary observes [2], "At a time when states are facing crises in health insurance spending and cutting lifesaving treatments, and when Texas leads the nation in the percentage of residents without health insurance, it is remarkable that Texas has chosen this path."

Crunching the Numbers

To heartwire , Khera, who read through transcripts of the testimony given during the bill's hearing, says he was "astounded" at some of the unsubstantiated "random numbers" that people were "throwing out . . . without any sort of evidence or way of looking at where those numbers came from." Conspicuously absent, he notes, was any kind of expert testimony from the American Heart Association or American College of Cardiology. As previously reported by heartwire , both societies stayed mum on SHAPE, drawing criticism for their silence, although the ACC told heartwire that their Texas ACC chapter "officially supported this piece of legislation and [was] glad to see that it has passed."

For many prominent cardiologists who were involved in SHAPE--most of whom don't hail from Texas--the bill's passing in some ways validates the work of their organization. Several SHAPE members have told heartwire that they believe their aggressive support for population-based screening fills a void that the professional societies have been too slow to move into.

Khera sees it differently. "I'm a Texan, and that's part of it. For those of us who actually live in Texas, these are real numbers, and real people, and real dollars."

Legislation Takes Shape in Florida

Khera's commentary comes on the heels of a recent announcement from the SHAPE society that the State of Florida is poised to consider Senate Bill 360, inspired by the Texas bill, which would require insurance reimbursement for up to $200 for CAC and CIMT screening. The bill, sponsored by Florida State Senator Mike Fasano,has been submitted and assigned to committee; the Florida legislature begins its sessions tomorrow.

A SHAPE spokesperson has said that while the society has not been consulted on the bill, it "has offered to provide information to substantiate the scientific basis for integrating atherosclerosis tests into a patient's routine medical regimen as men and women age."

Last November, the SHAPE society sent out a press release telling reporters that its task force was poised to release a new set of guidelines for noninvasive coronary disease risk screening with calcium scoring and ultrasound. A spokesperson also told heartwire that it would be publishing this update in a peer-reviewed journal.

The original SHAPE "guidelines" were criticized for being published in a Pfizer-sponsored supplement to the American Journal of Cardiology rather than having gone through the traditional peer-review process.

Contacted by heartwire , a SHAPE spokesperson said today that the writing committee for the SHAPE II guidelines has "not yet completed their work on the journal submission" and clarified that what was announced in November was that "the committee had reached consensus and the writing was under way."

Asked what he thought about a screening bill now being considered in Florida, Khera said, "In some ways, I can understand why: this is the number-one cause of death, and I certainly appreciate that legislators want to do something, because people are dying from heart disease."

But he hopes his paper may play a role in giving people some pause for thought. "It's not to say we shouldn't move forward, and this is well intentioned, but we need to know what we're doing before we go off and implement laws."

Khera disclosed serving as a consultant for Daiichi-Sankyo.

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