Coronary CTA: Can it survive?

March 4, 2008

CMS stirs up hornet’s nest with threat to disallowan option for local Medicare coverage decisions and prohibit cardiac CT angiography for all but trial patients

In a week or two, the Centers for Medicare and Medicaid Services will weigh in with its decision on whether to overturn local Medicare coverage of cardiac CT angiography for the diagnosis of coronary artery disease. Its proposal, made last December, to change the current approach would make an exception only if patients were enrolled in research trials preapproved by Medicare. It sent a collective shudder down the spine of medical practitioners in the U.S.

Physicians across the U.S. are now being reimbursed by Medicare for coronary CTA thanks to determinations made individually by local third-party payers. This CMS policy, which allows insurance companies contracted with Medicare to cover procedures as they see fit, has bridged the reimbursement gap that typically exists between the introduction of a new technology and CMS’ issuance of a national coverage policy. These local coverage decisions have helped cardiac CTA to spread, which has fostered enough positive research to convince several medical societies to embrace it. This in itself is worth noting, as the groups that have agreed on coronary CTA don’t agree on much.

December’s surprise announcement by CMS, that “the evidence is inadequate to conclude that cardiac CTA is reasonable and necessary,” sent these societies and many others scrambling to comment within an unusually narrow 30-day window. The window closed in mid-January, and CMS’s final decision is due in mid-March.

Submitted comments seen by Diagnostic Imaging call on CMS to leave the current system in place or, at least, change the way the Medicare agency would evaluate cardiac CTA when making a national coverage decision, eliminating clinical outcomes as a metric, as they are not well suited to the assessment of diagnostic technologies. Alternatively, a national registry has been proposed in place of CMS-approved clinical studies, as such a registry would allow the agency to keep track of cardiac CTA utilization while it formulates a national coverage policy.

There is a lot at stake. If CMS restricts coverage, as it has proposed, many patients who would have benefited from cardiac CTA will not. Some fear the precedent could also have a chilling effect on Medicare contractors, who may be less inclined to make local coverage determinations regarding other emerging technologies, such as CT colonography, than they have in the past.

This effect could spill over into the development of emerging technologies. Faced with greater than usual uncertainty about the adoption of new products, equipment developers might play it safe by shifting R&D dollars from promising but speculative technologies toward those more in the mainstream.

The U.S. public would be hurt in the near and long terms if CMS goes forward with its plans, according to our roundtable Q&A of industry executives. Through individual interviews, Diagnostic Imaging has assembled opinions from executives at the leading makers of CT scanners: Dr. Donald Rucker, Siemens Healthcare chief medical officer, who applies his medical training as an emergency room physician in the University of Pennsylvania Health System and serves on the Medicare Coverage Advisory Committee; Mike Becker, general manager of global reimbursement for GE Healthcare; Doug Ryan, senior director of the CT business unit for Toshiba America Medical Systems; and John Steidley, Ph.D., vice president of global marketing for CT at Philips Healthcare.

Diagnostic Imaging: What’s your take on the proposed change in CMS policy?

Philips VP Steidley: We feel it is the wrong decision, and if it is made and upheld, it will not allow coverage for a lot of patients who really need this technology to diagnose their disease early enough to make a difference in their lives. I think it would be a very sad day if this goes through.

Siemens CMO Rucker: As a doc, my analysis focuses on what is the best choice for the patient among several options: whether to test or not and what kind of tests to run-or whether to treat or not. In the national coverage determination being proposed, these broader questions are not raised.

Toshiba exec Ryan: Our customers with cardiac CT have told us this is a great test and that it is benefiting patients. They are concerned that it will be taken off the table.

GE exec Becker: It all comes down to patient access to this procedure. Right now you have a technology, cardiac CTA, that is in widespread use across the country not only in the Medicare population but also in the private payer population. It is concerning to put in a restrictive coverage policy that takes a couple steps backward in the quality of care.

DI: In pulling back from local coverage decisions, it seems CMS is saying this approach is broken. Is it?

Siemens CMO Rucker: I think the process has largely worked to date. The benefit is that you have more eyes on the problem.

GE exec Becker: CMS might not appreciate what they have done over the last several years to create this coverage. It bridges new technologies and gets them adopted into the marketplace more quickly.

DI: If the system is working, why “fix” it?

Philips VP Steidley: I think CMS is afraid that cardiac CTA is going to add another layer to diagnostic testing, that people will do CT, then nuclear, then cardiac cath, and then the intervention.

But there are compelling stories about how this technology improves care and cuts cost. One cardiologist in private practice who started using CT in 2005 told us he was able to see 30% more patients. He reduced waiting time for appointments and provided intervention at an earlier stage of disease. He decreased his volume of diagnostic cardiac cath by more than 80%, and his group as a whole dropped its volume (of diagnostic cardiac cath) by 60%. In the two-year period of 2005 and 2006, they reduced the number of nuclear stress tests and, overall, saved third-party payers $2.8 million.

DI: I’ve heard other stories like this, but are there enough of them? Should there be more validation?

GE exec Becker: Medical societies have independently reviewed and validated the technology, adopted it, and drafted their own appropriateness criteria to ensure that it is used properly. You have FDA clearance. You have local coverage decisions in place throughout the 50 states by the local Medicare contractors, which were empowered to independently review evidence and, after doing so, made coverage decisions.

Siemens CMO Rucker: These local determinations are relatively tight on the use of cardiac CT angiography, but open enough to allow the medical community to learn about its value. We’re hearing right now that there are more clinical articles soon to be published on high-resolution cardiac CTA than have been published throughout its entire several years of existence. The current reimbursement process is allowing the generation of massive amounts of data on where and how this technology should best be used.

DI: The paradox is that CMS wants to make an important coverage decision literally months before these data become available for its evaluation.

Siemens CMO Rucker: We would like to see them wait a year to let this information come in. It is worth understanding that in every single study of high spatial, high temporal [resolution] cardiac CTA that we have seen, the modern scanner has shown spectacular results. This is not an area where half the studies are sort of plus and the other half show marginal benefit. All these studies are showing spectacular results. Every single result is pointing in one direction.

DI: CMS seems to be directing attention to the technology’s effect on outcomes, rather than its diagnostic capability. Is this reasonable?

Siemens CMO Rucker: All you can ask reasonably and scientifically of a diagnostic test is whether it gives accurate and reproducible results. In this case, you have to ask, is the nature of CAD as seen in a cardiac CTA scan different from what is seen on cardiac cath, or is this information not transferable? That is the only reasonable way to tie cardiac CTA to outcomes studies. And what all these studies are showing is that coronary CTA highly reproduces cardiac cath results, with the added bonus that you can actually see plaque.

DI: This is in patients who have signs of CAD. But there is also value in identifying patients who don’t, right?

Siemens CMO Rucker: Negative predictive value is very important for many patients. We’re seeing very high negative predictive values, from 95% to around 99%, so we can confidently say which patients do not have the disease. And we are already seeing early research that shows massive reductions in emergency department costs as a result. People coming in with chest pain-who would otherwise have been admitted-get a cardiac CTA that proves negative and are sent home. We are aware of unpublished information that shows this can be done with extreme safety.

DI: In a letter sent to CMS during the public comment period, Philips Healthcare asked the agency to confirm that any final decision in this matter not apply to the use of CT outside of coronary artery disease. It sounds like you are worried that changes in coverage of cardiac CTA could spread to other indications.

Philips VP Steidley: That is correct. There are a lot of tests already in place that have not had to meet the burden of proof that CMS is considering for cardiac CTA regarding CAD. There are nuclear cardiology and other kinds of tests that have not been asked to demonstrate improved outcomes. And if they are, it would an unfair burden on them.

DI: What about emerging technologies. How might setting such a precedent with cardiac CT affect the industry’s R&D?

Philips VP Steidley: If you have to prove positive outcomes for a diagnostic test, it is going to restrict the appetite of business to invest in promising new diagnostic technologies. Right now we let market forces sort out a lot of these issues rather than trying to regulate them in advance. We think informed patients and physicians who have the best interest of their patients at the center of their decision making will pick the best tools. We think it is our job to come up with new and innovative technologies.

GE exec Becker:  We are concerned as well that this could set a precedent as we look beyond coronary CTA. I am hopeful that this is just a rushed kind of decision that came at the end of the year and at a busy time, and maybe they didn’t think through the ramifications of what they were doing. I don’t think CMS is inherently biased toward delaying technologies. I think they, too, want the best technologies for Medicare beneficiaries.

DI: If not, if the proposed policy for cardiac CT is a harbinger of things to come, the next test to be affected could be CT colonography.

Toshiba exec Ryan:  I think that is why we need better communications with CMS. We need to develop a strategy that we can use to communicate the benefits and costs of new technologies. This would allow us to tell CMS when we see growth in procedures so that we can explain it and show that this growth is occurring because a valuable test is coming into use.

DI: So the idea is to take a proactive approach?

Toshiba exec Ryan: Absolutely. We shouldn’t be waiting for the guillotine to drop before we look into why it came down. This is something we need to look at ahead of time, as an industry. How do we approach the insurance companies, as well as CMS on a broader basis, to prevent things (like the cardiac CTA situation) from happening? There is a lot of emotion involved in this, particularly from physicians who have been heavily involved in patient care using this technology. There has to be a better way to address things like this.

DI: How?

Toshiba exec Ryan: We need a unified approach. If we come at it from separate directions, the likelihood of success is very low.

DI: So the community would work through groups? Vendors through the National Electrical Manufacturers Association and physicians through their societies would work together to create a single approach to represent the medical community?

Toshiba exec Ryan: Correct. The physicians, vendors, and societies have to approach this together. But first we have to determine the best way to approach CMS and insurance companies.

DI: We could be only days away from a decision. What do you think will happen?

Philips VP Steidley: We believe they will reconsider and back off this proposal. We hope it will be withdrawn, fully withdrawn. If it is not, certainly we hope CMS will keep indications open and eliminate the burden of a full-blown clinical trial and maybe have a national registry in place to track utilization and make sure cardiac CT is not turning into a layer test of cardiac CT, followed by nuclear, and then by diagnostic cath, and then intervention. A registry would prevent the abuse of this technology and, really, I think CMS proposed this policy to prevent abuse, not to stop a great technology from helping patients.

DI: Let’s suppose the worst, that CMS goes ahead and restricts Medicare reimbursement of cardiac CTA as it has proposed. What happens next?

Siemens CMO Rucker: This technology is so revolutionary and powerful, and predictions about the diagnosis of treatable CAD with preventable morbidity and mortality are so high, that sooner or later the demand from physicians and patients will lead CMS to support cardiac CTA. It is my personal belief as a physician that this is such a superior technology from the cost, safety, and efficacy points of view that it will dominate.

Philips VP Steidley:  It’s a little bit unusual that all these physician groups can agree with each other. When they do agree, it is usually a pretty good argument in favor of something.

GE exec Becker:  To me, that says CMS missed something on this one.

Siemens CMO Rucker: If CMS doesn’t see this immediately, we will still use cardiac CTA on non-Medicare patients. The scale of investment in this technology is global by the companies making the equipment, so we will get data on its effectiveness from throughout the world. So unless the data, which have been overwhelmingly and stunningly positive, suddenly change direction-and we haven’t heard a single thing to suggest that this will happen-the data supporting the use of coronary CTA will continue to pile up. I think Medicare, over time, will have to acknowledge it.