The battle for healthcare reform has begun in earnest now, with U.S. President Barack Obama stumping for far-reaching change to an audience of physicians fearful of pay cuts, healthcare insurers wary of government competition, and skeptical consumers whose views often reflect their own access to care.
If past is prologue, coronary CT angiography (CTA) faces a tough battle for coverage in an era when "comparative cost-effectiveness" -- and how it is defined -- will dominate critical coverage decisions that will increasingly take place on a national stage rather than locally.
According to a cardiologist who makes a living from coronary CTA, both performing and advocating it, CTA's powerful opponents have not only waged an unfair battle in the media, they've been less than candid about disclosing their interests.
In the closing talk at last month's International Symposium on Multidetector-Row CT in San Francisco, interventional cardiologist Dr. Tony DeFrance warned that political effectiveness will be as important as cost-effectiveness in gaining broad coverage for coronary CTA in the U.S.
From the clinical standpoint, early studies show that coronary CTA can triage chest pain patients and send them home more safely and cheaply than the current standard of care, for example. But study conclusions notwithstanding, the outcome of the battle for coronary CTA could well depend on who succeeds in defining the battlefield, DeFrance said.
"A lot of it comes down to coronary CTA as a kind of poster child" for the struggle over technology adoption policy -- that and physician revenue streams, said DeFrance, who is an associate professor of medicine at Stanford University in Stanford, CA, and chief of cardiac imaging at the Nevada Imaging Center in Las Vegas.
Two realities
"Cardiac CT is a very powerful tool. It's safe and noninvasive, and we're getting more and more evidence of its effectiveness," DeFrance said. "So why is there all this resistance to adoption?"
The scientific reality is that coronary CTA isn't a perfect tool, but it's an extremely good one.
Its niche in patient care is being rapidly defined as a robust exam with a negative predictive value of around 99% for ruling out coronary artery disease, he said. On the other hand, more cost-effectiveness data and more trials comparing effectiveness with the standard of care are needed.
Media menace
"The media reality is that there's been widespread criticism, and we've had negative editorials in the journals," DeFrance said. "And maybe it's just coincidence, but there seems to be a fairly coordinated press campaign in that these negative press releases come out just at critical times -- like before the (2007) Medicare decision, etc."
The mountain of negative press has included newspaper and journal articles citing outdated and excessively high radiation doses, theoretical cancer risks described as a matter of fact, and authors who have suggested that coronary CTA scans delivering "scant evidence of effectiveness" are being conducted in a single-minded bid to keep scanners busy and physicians paid.
A 2008 New York Times story noted that more than 1,000 hospitals and private cardiology practices had bought or leased the $1 million CT scanners used for CTA and other imaging procedures.
"Once they have made that investment, doctors and hospitals have every incentive to use the machines as often as feasible," authors Alex Berenson and Reed Abelson wrote (New York Times, June 28, 2008).
Characterizing CTA as a "tool of dubious value," the authors noted that under U.S. Food and Drug Administration rules CT manufacturers "do not have to conduct studies to prove that their products benefit patients." Rather, "a faith in innovation, often driven by financial incentives, encourages American doctors and hospitals to adopt new technologies even without proof that they work better than older techniques," the team wrote.
Cardiologists using the scans are simply practicing medicine the way the health system rewards them to, Georgetown University economist Jean Mitchell told the Times. Given the opportunity to recommend a test for which they will make money, doctors will use it. "This is not greed," Mitchell said. "This is normal economic behavior."
In a November 27, 2008, New England Journal of Medicine editorial discussing the results of the CORE 64 CTA trial, cardiovascular imaging specialist and health policy advisor Dr. Rita Redberg from the University of California, San Francisco (UCSF), and colleagues dismissed the evidence in favor of coronary CTA scans (NEJM, November 27, 2008, Vol. 359:22, pp. 2324-2336).
"There is no data. Cardiac CT is just a bunch of pretty pictures," Redberg and UCSF professor of medicine Dr. Judith Walsh wrote in a widely criticized editorial, entitled "Pay Now, Benefits May Follow" (NEJM, November 27, 2008, Vol. 359:22, pp. 2309-2311).
DeFrance said the authors' "fairly negative article barely even touched on the topic of study design or the factors" behind the results. "Mainly it was a kind of a pedestal to talk about certain Medicare decisions."
Among the modality's more vociferous opponents, Redberg receives funding from healthcare giant Blue Cross Blue Shield, which has opposed the adoption of coronary CTA, DeFrance said. And while there's nothing wrong with opposing the technology, those who do so need to disclose their potential biases, he said.
Third-party payors are worried about the cost of CTA, DeFrance said. "Will this cause layers of testing, and will this add to the cost of care? Some of this is valid criticism -- we do need more data," DeFrance said.
Early studies have shown significant savings with the use of coronary CTA versus the standard of care, including stress testing, cardiac enzyme tests, invasive coronary angiography, and inpatient observation.
Get scanned here now
A wave of entrepreneurial physicians pushing coronary artery calcium scans in the early days hasn't helped the political situation, DeFrance said. High radiation doses, now being reduced substantially with new techniques, have also slowed acceptance, he said.
Physicians who stand to lose money are an obvious source of opposition to CTA, he said.
"I am a cardiologist, but there is a heavy vested interest against this succeeding because of people's revenue streams," DeFrance said. "It's no secret that cardiologists make the majority of their money from nuclear [medicine scans] or at least a good percentage of it -- and from invasive catheter angiography. So some people don't want the status quo to change."
Cost-effectiveness and technology assessment
But the major struggle under way is the fight over what criteria will be used to determine the future of technology adoption policy in the U.S., DeFrance said.
"The reality of the times is that healthcare costs are at 17% of gross domestic product representing trillions of dollars in spending, double-digit growth in imaging costs over the last few years, and control of technology adoption is seen as essential to controlling healthcare costs," DeFrance said. "You see this in the headlines almost daily now, and you see these terms again and again: cost-effectiveness and comparative effectiveness."
With hard choices being made regarding the best use of scarce healthcare dollars, CTA is certain to be a flashpoint for these competing interests. Advocates of CTA see new barriers to technology adoption as a way to keep the inefficient status quo from changing.
Stakeholders in the coronary CTA debate include cardiologists, radiologists, medical societies, and vendors. At this point patients don't really play a role, DeFrance said. Some stakeholders favor the development of comparative-effectiveness data, while others are pushing for long-term outcomes data requiring lengthy and expensive trials.
Other major players are entities such as the Baltimore-based Center for Medical Technology Policy, which receive most of their funding from third-party payors. These organizations want to position themselves as an additional layer between technology development and clinical adoption. But they've been less than up-front about their funding, their plans, and the extent of their influence on government decisions -- disclosure that is essential for fostering honest debate, DeFrance said.
At this point, it's unclear who will emerge on top, be it Medicare, third-party payor-funded companies, a proposed national institute of clinical effectiveness, and/or the National Institutes of Health, he said.
But it is a high-stakes game, he said, unfolding in an era of sharply constrained budgets, massive deficits, and the new administration's determination to pass major healthcare reform legislation by October. But the core issue is technology adoption policy, which will "remain on the front burner," DeFrance said.
"We've come to the conclusion that it's not really about cardiac CT scans, the specificity, the sensitivity, the negative predictive value," DeFrance said. "A lot of it comes down to coronary CTA as a kind of poster child" for the struggle over technology adoption policy -- that and physician revenue streams, he said.
DeFrance said he's not against technology adoption policy, but "we need defined standards, and we need to know what hurdles we're jumping over."
"There can't be a changing bar, and we need to make sure new technology is helping patients," he said. "Who is going to pay for the burden of proof? The insurance companies don't want to pay for these multimillion-dollar outcome trials."
CTA wins one
Questions about outside influences on Medicare became a factor in a 2007 proposal by the Centers for Medicare and Medicaid Services to stop CTA funding under local coverage decisions and limit the test to approved trials. Medicare was charged with using a Blue Cross Blue Shield Technology Assessment critical of CTA as the basis for its proposal, which was abandoned in the wake of stiff opposition from providers, patients, and other "grassroots" CTA advocates, DeFrance said.
"It was because of the public outcry that we got almost 80 signatures from Congress, and the Senate that went to [CMS] in a flood," he said. "The reason we fought so hard is because this would have really shifted the power away from physician societies controlling [CTA] to potentially biased groups making these decisions."
The bottom line is that "technology adoption is under massive scrutiny," DeFrance said. I think this is a warning sign for future imaging modalities -- if you look at what happened to virtual colonoscopy, it's a warning sign."
Last month CMS denied coverage for virtual colonoscopy screening, citing a lack of sufficient data. The importance of technology assessment was not lost on advocates of the decision.
A May 27 editorial lauding the CT colonography (CTC) denial, authored by UCSF's Redberg and colleagues, referenced the 2007-2008 skirmish over coronary CTA when it welcomed the CTC denial as "a departure from some of its past decisions" (NEJM, May 27, 2009).
"When the CMS reopened its consideration of cardiac CT and issued a narrower draft decision memo, it received a flood of letters [from CTC advocates] in protest," the editorial stated. "In the face of these letters and considerable congressional pressure, and thanks to an internal decision that withdrawing coverage required evidence of harm or lack of benefit, the CMS withdrew the more restrictive draft national decision and issued a final decision that maintained generous local coverage. Given this history, we worry that the CMS may waver in the face of the struggle between science and politics."
Hearts and minds
DeFrance called radiation dose, limited reimbursement, and the negative media campaign the principal reasons coronary CTA implementation has lagged. In the battle for CTA coverage, political effectiveness will be as important as cost-effectiveness, he said.
Getting coronary CTA approved for the indications it handles best will require stakeholders to remain keenly informed about the issues, including comparative- and cost-effectiveness criteria as well as sound study design.
"Keep the for-profit insurers out -- or at least have them disclose their interests," DeFrance said. "And make technology adoption thresholds reflect safety concerns, common sense, and how significant a disease it is. Cardiac disease being the No. 1 killer, this is an important subject, and then get involved in a society that advocates it" -- for example the Washington, DC-based Society for Cardiac Computed Tomography (SCCT), he said.
By Eric Barnes
AuntMinnie.com staff writer
June 19, 2009
Related Reading
CMS rejects Medicare coverage for virtual colonoscopy, May 12, 2009
CMS makes no change to coronary CTA payments, March 12, 2008
Pending Medicare decision roils cardiac CTA, January 8, 2008
Low-dose coronary CTA diagnoses most patients, November 28, 2007
Scientists doubt utility of CT scan as heart test, November 30, 2008
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