CMS Moves to Halt Medicare Reimbursement of CT Angiography, Except in Clinical Trials

Shelley Wood

January 14, 2008

January 14, 2008 (Washington, DC) - Proponents of cardiac CT angiography (CTA) are, in the words of one clinician, "in uproar and panic" over a proposed national coverage determination (NCD) by the US Centers for Medicare & Medicaid Services (CMS). Far from establishing national Medicare coverage for patients undergoing CTA--something that all 50 individual states already provide under local coverage determinations--the federal policy decision would limit Medicare coverage of a diagnostic CT to just two indications and only in cases where the patient was enrolled in a clinical trial of cardiac CT.

"Usually when you hear 'national coverage determination,' that connotes good, it means the modality or therapy will be covered nationally," Dr Michael Poon, president of the Society of Cardiovascular Computed Tomography (SCCT), one of the organizations protesting the proposed NCD, lamented to heartwire . "But unfortunately this time, they've added another acronym, CED--coverage with evidence development--which is a totally different ball of wax. What it means is CTA will be covered only if the patient is enrolled in some kind of clinical trial."

No preexisting national Medicare policy deals specifically with coronary CT angiography; until now, Medicare reimbursement has been governed by local coverage determinations at a state level, where local contractors variously opted to cover CTA between 2005 and 2006. CMS spokesperson Don McLeod confirmed to heartwire that a national policy would trump all locally established determinations.

The proposed NCD was drafted in December 2007 and is open for a second round of public comment until January 13, 2008. If adopted, the determination would take effect in mid-March 2008 and would limit Medicare coverage of CTA for the diagnosis of CAD in symptomatic patients enrolled in a clinical trial presenting with either "chronic stable angina at intermediate risk of CAD or with unstable angina at low risk of short-term death and intermediate risk of CAD."

According to Dr Pamela Woodard, president of the North American Society for Cardiovascular Imaging, which is also objecting vociferously to the draft NCD, the actual indications suggested represent only two of the "useful" patient populations.

"However, there are others," she noted. "For example, patients who may have abnormal stress tests in low- or intermediate-risk populations who might otherwise go on to cardiac caths. But the CMS is basically only including patients at intermediate risk."

In the face of evidence

The CMS Coverage and Analysis Group responsible for the draft NCD, led by Dr Steve E Phurrough, asserts that there is not enough evidence to support Medicare coverage of CTA.

But proponents of CTA who spoke with heartwire say that the proposed NCD does not take into account many CTA studies that have been published or presented since the CMS first announced it was looking into CTA reimbursement, back in the summer of 2007.

"We knew that the CMS was coming out with a proposal; we didn't know it was going to be an NCD," Woodard told heartwire . "The opinion of the societies is that the CMS ignored a lot of literature that is already out there in its NCD proposal. We know that there are about 20 to 24 articles that are not cited. One of the concerns was the lack of multicenter trials; however, there were two multicenter trials that have been presented at the AHA and RSNA [meetings]. . . . That information was also not considered."

McLeod, however, speaking for the CMS, insists that "this is a science-based process," adding that the CMS decision takes into account evidence it finds on its own and any submitted through the open public comment. Whether that includes the most recentclinical data presented or published is unclear, something many imaging experts allege has not taken place in this case, given the fast-paced accumulation of data supporting a role for CTA. But Dr Barry Straube, the CMS chief medical officer and director of its office of clinical standards and quality, rejected this concern, telling heartwire , "The charge that evidence published in the last year was not used is incorrect. CMS will review all public comment and decide whether the proposed decision memo should be modified or not."

Turning back the train

Dr Armin Zadeh is one of nine imaging experts at Johns Hopkins University who have signed onto a letter to Phurrough, inviting him to visit their cardiac imaging lab to better understand the benefits of cardiac CT angiography. He believes the cardiac imaging societies duly provided feedback during the initial public comment period but did not "take seriously" the CMS threats that an NCD was in the works.

"We really didn't think they'd go through with this, so that's why everybody was shocked when they came out a few weeks back and said that they are ready to implement this. If you read it, it already sounds like a final decision. It's open for discussion, but the chance that they'll actually revoke it is pretty slim."

Zadeh notes that, in the past, the CMS has rarely gone back and rejiggered a proposed or finalized NCD for cardiac imaging, even after evidence supporting a benefit of the technology on hard outcomes is in. "A similar thing happened with PET scanning, which has never really gotten reimbursement," he told heartwire .

Poon, likewise, is concerned it may be too late to turn the train around. "Unfortunately, this is an election year, and politicians have bigger fish to fry than worry about cardiac CT," he said ruefully. "I don't think politicians are interested in saving a modality when there is so much discussion about cost containment and the Deficit Reduction Act and so on."

Radiation risks

In recent months, risks associated with CT angiography--particularly the amount of radiation it delivers--have been under increased scrutiny. At last year's AHA meeting, Dr Michael Lauer (National Heart, Lung, and Blood Institute) delivered a stinging rebuke to the field as a whole, calling for a moratorium on cardiac CT until proof of safety and benefit was in. Contacted by heartwire , Lauer's office said he "would not be commenting" on the proposed CMS coverage decision.

"Obviously there are concerns regarding radiation, which are legitimate, and I don't think we should be using CT in everybody," Zadeh told heartwire . "But for the appropriate indications, these scans actually save lives by the mere fact that if, based on the CT scan, you don't do a cardiac catheterization you will inevitably save lives. The complication rate from cardiac catheterization is very well-documented. There is no doubt that people die during diagnostic catheterizations every year."

Zadeh acknowledges that the CED-portion of the proposed NCD may be to encourage clinical studies. In this case, however, "CT studies are just exploding everywhere," he said. "There is not a lack of data, it's just that many of these outcome studies take time. They are all in the planning phases or have already started. But there's no lack of willingness and interest in conducting studies."

Societies comment, then wait

A range of other cardiac and imaging societies have expressed their concern about the draft NCD, among them the American College of Cardiology, the American College of Radiology, the American Society of Nuclear Cardiology, and the Society for Cardiovascular Angiography and Interventions. A "Comment" button on the CMS website where the draft proposed decision memo has been posted allows physicians and other concerned parties to comment on the NCD until January 13, 2008.

In recent weeks, society presidents, including Poon and Woodard, having been trying to get the word out to their members to voice their opinions while there is still time.

"This is a very unfortunate, backward, and draconian move on the part of the CMS," Poon told heartwire . "What this means is that many Medicare beneficiaries will have to go back along the traditional pathway, which is, if you have an equivocal stress test, you get cathed. If you have atypical symptoms, or are unable to exercise, you get cathed. Right now we have CTA as the gatekeeper, so that many of the unnecessary caths can be avoided."

He notes that registry results suggest that as many as 40% of diagnostic catheterizations are unnecessary; other patients who undergo diagnostic catheterizations end up getting interventions for "quasi-indicated lesions" because they're already prepped and on the table, he adds. "Every state in the union accepted this technology as efficacious and beneficial before the CMS turned an about-face, without any legitimate reason and without looking at all the published evidence. I think that is wrong, and I don't think it's fair to the Medicare beneficiaries."

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