National coverage for cardiac CTA will not change.

March 15, 2008 — To the relief of many in the cardiology and radiology community, the Centers for Medicare and Medicaid Services (CMS) announced this week that it will not change current coverage for Computed Tomographic Angiography, commonly called Multislice CT Scan, Cardiac CT or CT Angiography (CTA). In December CMS had proposed a National Coverage Decision (NCD) memo, calling for significant cut-backs in reimbursement for CTA, covering only symptomatic patients and only in the context of an approved Clinical Trial.

After the original proposal was announced, there was an intense outpouring of concern by the various stakeholders in the cardiac imaging community. Over 600 comments were posted to the CMS web site from a wide range of radiologists, cardiologists and patients, almost universally calling for CMS to re-think this change. Mainly through the efforts of the of The Society of Cardiovascular Computed Tomography (SCCT), 79 Members of the House of Representatives signed a letter to CMS to express concern about the proposed NCD and almost a dozen U.S. Senators wrote to CMS with their concerns.

Novel suggestions included that of Dr. Armin Zadeh of Johns Hopkins Medical Center, who invited the CMS team to visit his lab to see a true state-of-the-art CT facility. A joint letter was submitted by most of the major medical societies concerned with heart disease and imaging. Angioplasty.Org also posted an open letter to CMS, pointing to the increased patient safety afforded by this non-invasive test for arterial blockage.

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At the heart of most criticisms was the fact that CMS had been working with older data and had not looked at the most current results of important clinical trials, such as the CorE 64 and others — trials which proved, among other things, the very high 99+% negative predictive value of 64-slice Cardiac CT. Multislice CT is a relatively new technology, one that is advancing every month.The feeling among imaging specialists was that a great deal was at stake here because, as Dr. Daniel S. Berman, President-Elect of the SCCT told Angioplasty.Org, “There is very strong evidence that the CT coronary angiogram is the most accurate non-invasive test for the detection of coronary artery disease. Period! Nothing comes close.”

Dr. John McBarron Hodgson, past-president of the Society for Cardiovascular Angiography and Interventions, capsulized CMS’ concerns to Angioplasty.Org:

“CMS is afraid that everybody’s going to stack tests — that you’d get a CT, then a nuclear stress test, then an invasive cath. So, in our most recent letter, we have this consortium of radiologists and interventional and nuclear cardiologists and general bodies, and everybody’s in there together saying cardiac CT is good, don’t mess with it! We’re doing good here!”And we now have papers that are going to be presented soon, and the data’s really amazing. I mean, you can predict outcome, and we’ve gone on record now to say that if you have a normal cardiac CT, you do not need any other tests. So, that’s the kind of stuff that CMS is really interested in, that we will come out and say “Hey, if you’ve got a negative CT, you don’t need all these other tests”.

   

   

The various societies felt that it was their role to reassure and inform CMS about the latest trial results, as well as the guidelines currently in place. Angioplasty.Org recently spoke with Dr. Michael Poon, current president of the SCCT, who told us:”We are not advocating doing this on everybody. We are not advocating doing CTA on a patient who is asymptomatic. We have very clear guidelines, based on the published Appropriateness Criteria. I was on the writing committee and we specifically stated that this test is indicated in patients with symptoms suggestive of the presence coronary artery disease, in lieu of doing invasive angiography, which is a test that can be 30-40% negative for coronary artery disease.”

In addition to cost, concern has also been raised about radiation exposure from multislice CT — the subject of a number of studies. But radiation exposure is a moving target, as technological advances continue. For example, a technique called ECG-gating is now used by some, in which the X-rays are sychronized with the heartbeat and are only emitted during a small part of the heart’s motion cycle. Toshiba recently introduced “Dynamic Volume CT” with a 320-slice scanner which the company has said can reduce the patient’s radiation exposure by a fifth because it is able to scan the entire heart in a single beat. Dr. Hodgson states that with modern techniques, the radiation exposure is far less than that of a nuclear stress test, one of the most commonly-administered diagnostic exams — and one which he no longer uses. Radiation from Cardiac CT, he continues, has become the same or less than that of conventional catheter-based angiography, and avoids the complications from the more invasive technique.

Although CMS is leaving the current coverage in place, it included a number of recommendations and requests for further study in this week’s decision. In its conclusion, CMS stated:

“CMS wishes to foster the necessary health outcomes research and establish evidence-based diagnostic strategies by encouraging affected Medicare patients to enroll in rigorously designed studies. Absent any reported additional serious patient harms, further national coverage reconsideration of coronary CTA will depend upon peer-reviewed publication and critical evaluation of convincing new evidence.

“Additionally, we believe that current guidelines are inadequate to provide appropriate guidance to patients and providers as to the appropriate inclusion of CTA into the diagnostic milieu in the workup of chest pain. We are concerned that providers are using CTA as an additional test added to exercise testing and nuclear imaging rather than thoughtfully considering the appropriate mix of these tests. We encourage the specialty societies to quickly develop this type of guidance.”

(Originally Reported on March 12, 2008 by Burt Cohen, Angioplasty.Org — updated on March 15)