Several societies, including ACR and ACC, have published a joint release that disagreed with CMS' conclusions in the proposed coverage of coronary computed tomography angiography (CCTA) determination and believe that if implemented, the policy would have a profoundly negative impact on Medicare beneficiaries by limiting access to this technology for clinically appropriate indications.
The release was jointly submitted by the American College of Cardiology (ACC), American College of Radiology (ACR), American Society of Nuclear Cardiology (ASNC), North American Society of Cardiovascular Imaging (NASCI), Society for Cardiovascular Angiography and Interventions (SCAI) and the Society of Cardiovascular Computed Tomography (SCCT).
Instead of the proposed national coverage determination (NCD) adoption, the societies said that “CMS should continue to allow local Medicare carriers to determine coverage through the local coverage determination (LCD) process.” Because all 50 states and Washington, D.C., currently permit access to CCTA for “many Medicare beneficiaries undergoing evaluation for coronary artery disease (CAD),” the societies believe the local agencies are better equipped to evaluate access to the diagnostic tool.
Furthermore, if CMS chooses to move forward and establish a NCD policy, the societies recommended national coverage without requiring evidence development for several more indications.
The societies highlighted six reasons where the CMS decision is lacking, and why CMS should not adopt this proposed NCD, which are:
1. According to the societies, “CMS did not conduct an adequate, thorough analysis of all available relevant evidence.” The statement reported that CMS excluded from review significantly more published manuscripts with 64-slice CCTA than were included in their coverage analysis in lieu of other studies involving outmoded 4-, 8- and 16-slice MDCT scanners. Based on the new evidence, the societies “urge CMS to reconsider the appropriateness of a NCD.”
2. The societies pointed out that even though there are four multi-society manuscripts published that evaluate the appropriateness of CCTA, CMS only referenced one in the proposed NCD. The statement reported that the only manuscript that CMS chose to review did not include the evolving technology of CCTA, which are reflected in more recent multi-society manuscripts. As a result, the societies “strongly encourage[d] CMS to reevaluate the clinical value and appropriateness of CCTA with the available evidence at hand.”
3. The societies also stated that CMS’ indications for clinically-valuable indications of CCTA “ignore[d] several well-established applications of CCTA in patient populations not described in the proposed NCD.” The societies believe the indications should be included: the assessment for presence and course of coronary artery anomalies; coronary artery evaluation in individuals in whom prior clinical non-invasive coronary artery test data (e.g. ECG or imaging results) are equivocal or discordant; assessment of bypass graft location (e.g. internal mammary artery) prior to surgical intervention in patients undergoing repeat sternotomy; and coronary artery evaluation in patients undergoing non-coronary cardiac surgery. Though the societies are suggesting that the current proposed indications need to be inclusive, they do note “that screening asymptomatic patients with CCTA is inappropriate, and should not be performed as an initial diagnostic test.”
4. CMS’ definitions of patient populations for the proposed coverage with evidence development (CED) are inaccurate, according to the societies. Specifically, they deemed that CMS’ use of the term “chronic stable angina at intermediate risk of CAD” was inappropriate. For example, the societies cited the 2007 ACC/AHA guidelines for patient management with chronic stable angina, which states that chronic stable angina “is intended to apply to ‘adult patients with stable chest pain syndromes and known or suspected ischemic heart disease’ as well as those with ‘ischemic equivalents,’ (e.g., dyspnea on exertion or arm pain with exertion).”
5. The questions that CMS outlined for clinical studies to qualify for CED are inappropriately defined and are unlikely to yield beneficial information, according to the societies.
6. Finally, the societies said that “LCD status has fostered the development