ACC, MITA speak to multi-society effort to maintain CCTA Medicare coverage

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In a decision that could have gone either way, the Centers for Medicare & Medicaid Services (CMS) announced yesterday that it would not implement a policy that would have restricted reimbursement for coronary CT angiography (CCTA). The stunning reversal by CMS was a result, in part, of the combined efforts of various societies to effectively oppose the CMS proposal, according to Kim Allan Williams, MD, American College of Cardiology co-chair, in an exclusive interview with Cardiovascular Business News.

Through yesterday’s decision, CMS maintained the status quo that coverage should be determined by local contractors through the local coverage determination process or case-by-case adjudication. All 50 states and the District of Columbia have enacted local coverage determinations for CCTA.

On December 13, 2007, CMS proposed that CCTA fall under the national coverage determination, and requested responses to their proposal. Since the release of this decision, the various cardiovascular societies and associations have responded in varying approaches to inform CMS on the clinical benefits of CCTA, including a multi-society statement, which highlighted the clinical omissions from the initial CMS decision.

In a vote of support, Andrew Whitman of Medical Imaging & Technology Alliance (MITA) told Cardiovascular Business News that MITA “commend[s] CMS on considering all of the evidence presented to it, and realizing that there is significant support for coverage of CCTA.”

“This decision is something that can be observed in the long-term, because it garnered societies from both sides of the aisle—cardiology and radiology—to work together to alter the path of the CMS,” said Williams, who is also director of nuclear cardiology at the University of Chicago.

Williams said that no one society should take credit for influencing the decision of CMS; however, several took different tactics.

“Some societies within the coalition, such as SCCT [Society of Cardiovascular Computed Tomography] and MITA believed it was beneficial to approach Congressional members to optimize exposure to the situation,” Williams said.

MITA worked closely with SCCT and the North American Society for Cardiac Imaging (NASCI), ACC, American College of Radiology and others, and they showed their commitment to this cause, according to Whitman.

Some society members took a more clinical approach in pointing out through phone calls and emails to Congress the clinical benefits of CCTA in diagnosing patients with CAD.

“The cross-industry effort to put facts and information on the table were very positive, as well as many of the lobbying efforts. Everyone involved can also be proud of what they were lobbying for – better patient access to care that reduces the invasiveness and increases the confidence of diagnoses around the heart,” Gene Saragnese, vice president and general manager of CT and molecular imaging at GE Healthcare, told Cardiovascular Business News.

In response to advocacy efforts, approximately 80 members of the U.S. House of Representatives sent a letter to CMS urging them to reconsider the proposed national coverage determination, while at least a dozen U.S. Senators sent individual letters to CMS expressing their concerns. Both SCCT and MITA praised yesterday’s decision of CMS.

“We worked closely with CMS to present all the evidence. We obviously thank the members of Congress, who were very concerned about this proposed decision, which had a component to it. However, we worked closely with CMS, and brought CCTA experts from all over the country to show evidence that has been published, as well as evidence that is in the pipeline to be published to show the value of the test,” Whitman said. 

The CMS final decision memo issued yesterday notes that “the use of CTA has increased over the years due to advances in the technology and rapid diffusion of the machines outside the hospital settings. The initial single-slice CT machines produced poor quality images. In the late 1990s, 4-slice CT machines were introduced, with 16-slice and 64-slice CT machines following shortly afterwards. Image quality and performance reportedly increased with each model. However, questions remain on the indications for use.”

Williams does not view this final statement as an ominous sign for the future of CCTA coverage. In fact, he said “it is actually true that questions remain.”

“While CCTA has a proven benefit, it’s still a technology in development. Until the modality stops evolving, the indications always need to be considered,” he said.

Even CMS commented that “there has been rapid advancement of the CTA technology from the initial 4-slice machines to the currently favored 64-slice scanners.” As a result, both government agencies and cardiovascular and imaging societies are struggling with proving long-term benefits.

Williams noted that radiation dose from CTA is a consideration, especially in such at-risk patients as older women, who are more susceptible given the breast tissue exposure over the heart.

Published criteria and guidelines that specifically address this issue have been developed by various societies and associations, he said. And these will continue to evolve as the technology moves forward.

“Over the next 12-18 months, even more clinical and economic evidence will come forth, both of which should continue to be evaluated with any new technology,” Saragnese said.

While CMS said it does not specifically look at costs in evaluating coverage, Williams pointed to the fiscal benefits of performing CCTA on patients with CAD. These savings come about by limiting unnecessary diagnostic cath procedures on low- to intermediate-risk patients with acute chest pain. 

In fact, in their final memo, CMS said that “the critical appraisal of the evidence enables us to determine to what degree we are confident that: 1) the specific assessment questions can be answered conclusively; and 2) the intervention will improve health outcomes for patients.”

“Ultimately, this decision has a real effect on patients, who could have potentially had a gap in coverage for a technology that has revolutionized the way we treat heart disease,” Whitman said.

When CMS first proposed the coverage decision in December 2007, they requested public comment. The agency reported that it received 670 comments, 10 of which agreed with the decision, while 649 opposed it, and the remaining 11 provided no clear direction for coverage.

CMS gave the cardiovascular societies and the imaging industry the opportunity to respond, and they “weighed the evidence that was presented to them very seriously to produce a positive result,” according to Saragnese. Also, CMS showed their commitment to this process by never denying patients’ access to CCTA through this investigation, Saragnese pointed out. 

Williams concluded that the CMS decision will be tremendously beneficial. He also noted that the societies and associations should continue to unify in tackling difficult issues. “The stakeholders should always get together, because this is a perfect role for societies to undertake,” he said.