Medical Device Daily Washington Editor

As the saying goes, sometimes no decision is a decision, and such was the case in last week’s announcement by the Centers for Medicare & Medicaid Services to make no change to its current payment policy for computerized tomography for angiography (CTA).

In the March 12 announcement, CMS stated “that no national coverage determination on the use of cardiac computed tomography angiography for coronary artery disease is appropriate at this time.” CMS was considering covering such scans only for trials intended to develop evidence to support those uses.

Medicare imaging has been the source of ire for the Medicare Payment Advisory Commission (MedPAC), and CMS unilaterally undertook a review of CTA to establish whether it is money well spent. The outcome of the entire exercise is that CMS will continue to default to local Medicare carriers to decide on reimbursement for CTA in assessment of coronary artery disease (CAD), with angina serving as the index symptom.

CMS said the use of CTA “has increased due to advances in technology and rapid diffusion of machines outside the hospital,” and that “proponents have claimed that CTA may reduce the need for invasive coronary angiography.” Critics of such uses point to “the lack of evidence on outcomes and the limitations to the technology including uninterpretable/unassessable [arterial] segments and the health risks from the considerable radiation exposure.”

CMS’s statement noted that the Agency for Healthcare Research and Quality commissioned a technology assessment in 2006 that drew on 29 studies of CTAs of 16-slice machines or better. AHRQ concluded that “there is limited evidence regarding test performance ... for identifying, quantifying, or otherwise characterizing coronary artery stenoses.” AHRQ also concluded, “future work will need to examine these tests in larger, less selected populations representing” real-world clinical settings.

A 2005 study conducted by the Blue Cross Blue Shield Technology Evaluation Center (BCBS TEC) likewise concluded that the evidence “is insufficient to determine whether the use of CTA improves net health outcome or whether it is as beneficial as any established alternatives.” A 2006 update by the BCBS TEC that examined the efficacy of 64-slice scanning equipment concluded that the available evidence “is inadequate to determine whether CTA improves the net health outcome or is as beneficial as established alternatives.”

The agency summarized by acknowledging the “uncertainty regarding any potential health benefits or patient management alterations from including coronary CTA in the diagnostic workup,” adding that “no adequately powered study has established that improved health outcomes can be causally attributed to coronary CTA for any well-defined clinical indication.” However, while the force of opinion of the relevant medical societies “did not dispel the uncertainty of the test’s clinical utility, they did strongly favor maintaining the local coverage policies for CTA.”

“In light of this, CMS has decided to make no change in the current NCD,” CMS said, warning however that “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.” CMS said it was “concerned that providers are using CTA as an additional test ... rather than thoughtfully considering the appropriate mix of these tests,” and encouraged “the specialty societies to quickly develop this type of guidance.”

Laurel Sweeney, senior director of reimbursement for Philips Medical Systems (Malvern, Pennsylvania), told Medical Device Daily that the CMS non-decision makes sense for patients and deficit hawks. Regarding data that depicts the cost of high rates of imaging of Medicare patients, she said “that data will not show the [cost of] cardiac catheterization” that CTA replaces.

Sweeney said that one reason the agency is unlikely to issue an NCD approving payment – seemingly supported by the fact that local carriers in all 50 states are willing to pay – is that “there’s a lot of data that’s pending” on 64-slice CT, and because much of the extant data is from 16-slice equipment.

Local carriers are fans of the 64-slice configuration “because you can take the scan a lot faster,” which eliminates the problem of patients having to hold their breath for longer than is comfortable, Sweeney said. “The newer technologies also allow you to set the [radiation] dose to the patient’s weight,” which gives clinicians “better images so you don’t have to retake them.”

In addressing a question about whether higher resolution expands the rate of false positives, Sweeney said, “it’s the opposite” because of the uncertainty whether chest pain is angina. “You’re able to rule out a patient having to go to the cath lab,” she said, adding that CTA is “five to seven times less expensive than the traditional hospital-based catheterization.” According to Sweeney, the payment for CTA under the ambulatory payment classification schedule is $299.

Speaking for both industry and the medical societies, Sweeney said that CMS’s decision to scrutinize CTA was “a surprise to all of us,” partly because referral data for CTA do not suggest the physician self-referral problem that has MedPAC up in arms over mounting Medicare imaging costs. She said “the number of self-referrals [for CTA] is not contributing at all,” and that “most of overall imaging referrals are referred by primary care doctors,” not by specialists.

Andrew Whitman, VP of the Medical Imaging & Technology Alliance (Rosslyn, Virginia), said in a prepared statement that the association “applauds CMS for following through on its commitment to conduct a comprehensive evaluation of all the data before issuing its final coverage decision.” On the question of whether CMS should simply issue an NCD for coverage, he told MDD “I think CMS made the correct decision to leave it with the local carriers” because the CED process “is used in instances where the evidence is not always 100% there, and here it was evident that the data support” the use of this technology for CTA.

Bridget McNeil, a spokesperson for the American Heart Association (AHA; Dallas) said AHA is still reviewing the decision and had no comment at this time.