Six societies, including ACC and ACR, oppose CMS restrictions on CCTA
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.”The joint release concluded that the “societies are cognizant of the challenges that advances in imaging may pose in light of the ever-increasing healthcare delivery costs faced by the Medicare program and private plans as well. To reinforce their commitment, the societies highlighted their “work developing Appropriateness Criteria and projects to promote their implementation in the practice setting, along with our society-led development of data registries under ACRIN and NCDR leadership to further promote imaging quality for purposes of determining and promoting both efficient and cost-effective care continues to demonstrate our commitment to addressing payors’ needs for assistance in these regards.”
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 of ground-breaking clinical trial research and registry data collection to answer questions about the utility of CCTA. In juxtaposition, the societies believe that the proposed NCD will only slow the development of evidence by academia, societies and registries rather than accelerate it.
The statement was sent directly to Steve E. Phurrough, MD, director of Coverage and Analysis Group, Office of Clinical Standards and Quality at CMS; and copied to CMS Acting Administrator Kerry Weems, CMS Director Herb Kuhn, and CEO of ACC Jack Lewin, MD.