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An Open Letter to the Centers for Medicare and Medicaid Services (CMS)

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Proposed Decision Memo for Computed Tomographic Angiography
-- Centers for Medicare and Medicaid Services

January 13, 2008 -- We at Angioplasty.Org urge CMS to extend the comment period and to consider the complications inherent in standard invasive angiography before deciding to restrict coverage for Computed Tomographic Angiography (CTA).

Recent studies of multislice CTA have shown extremely high negative predictability, equal to, if not better than, standard catheter-based invasive angiography. Considering that most data show at least one-third of invasive angiograms are negative for significant coronary artery disease (CAD), CTA presents several advantages for patients. The risk of death or stroke in a standard angiogram is extremely low, but it exists -- about 1 in 1,000.

But a much more significant source of complications that is not discussed much is the area of vascular injury: bleeding and nerve damage at the arterial access site, usually the femoral (groin) approach. The most popular topics in the Patient Forums on Angioplasty.Org (unfortunately) are about complications after an angiogram or angioplasty, directly due to access site complications or closure device complications. Any interested party should go to our Forums and read these stories. While some of these postings describe only annoyances which resolve themselves, many of our patients end up with permanent disability from their angiograms. Some of these patients who have had angiograms wound up having no coronary artery disease, but they now have lost their ability to run, bike, or drive a car without pain. When assessing the cost-effectiveness and safety-effectiveness of CTA, CMS must factor in the vascular complications caused by invasive angiography -- 3% at the minimum. Furthermore, it is well-known that nuclear stress tests have a significantly higher false positive rate in women, and that, as a result, many more women than men end up having invasive angiograms which show no significant CAD.

A technology that can reduce the complications caused by invasive angiography would be a welcome one, and CTA is certainly an excellent candidate. Like any technology, it can be open to abuse by the untrained and uninformed. But restricting reimbursement for CTA will have a significant and detrimental effect not only on the further development of this technology but also on the training process. Few physicians will spend the time and money out-of-pocket to learn how to best perform CTA if there is no reimbursement. Thus the level and availability of high level patient care will shrink. Rather than restricting reimbursement, CMS should be encouraging physicians to learn the latest techniques for performing and interpreting CTA, many of which involve techniques which vastly reduce radiation exposure.

The concerns of CMS are not unfounded and not new. In the 1970s, Dr. Melvin Judkins, the inventor of the femoral approach for catheter-based invasive coronary angiography, expressed great concern to his colleagues that his technique was perhaps too easy to perform, and because of that, it might be abused and overused. One of his solutions was to found, along with Mason Sones, the Society for Cardiovascular Angiography and Interventions (SCAI) in order to set standards for angiographic technique.

Dr. Andreas Gruentzig, who in 1977 performed the first coronary angioplasty, felt similarly. Despite these reservations, both promoted their techniques and established training venues so that cardiologists who decided to use these procedures would do so at a high level of competence. Gruentzig invented the live demonstration course and established the NHLBI registry to track patients and outcomes. He advocated for clinical trials, comparing angioplasty to bypass surgery. But he never limited the technique to patients who were enrolled in such a trial. He knew that there were many patients who could benefit from his discovery: to have their arteries opened without surgery.

Neither Judkins nor Sones nor Gruentzig advocated the type of severe restriction currently being applied to CTA. If they were alive today, I am sure that they would be sending their comments to CMS in favor of expanding coverage, especially to qualified centers and/or physicians.

We are also concerned over the timing of the public comment period. The 30 day comment period spanned the Christmas and New Year's holidays and effectively reduced the 30 day period to 15 days. This is an extremely important decision and we at Angioplasty.Org strongly advocate that CMS extend this period to give a fairer chance to those who might have commentary that could significantly impact CMS's decision.

We thank you and hope that your decision is made with the safety of the patient in mind.

Burt Cohen