Societies blast governments decision to restrict CTA payment
CMS aims to cutback reimbursements for CTA. Source: GlobalSpec  
In record time, all 50 states enacted local coverage determinations to pay for coronary CT angiography. That amazing consensus is about to be undone in one fell swoop by the Centers for Medicare and Medicaid Services.

CMS has proposed a very limited coverage of CCTA which could take effect as early as March 13. Cardiology societies have responded with a statement denouncing the government’s approach. 

The statement asserts that if the proposed changes go through, they would have a profoundly negative impact on Medicare beneficiaries.

CMS’s proposed national coverage decision requires the initiation of a clinical trial to establish whether CCTA is useful for either of the following types of patients:
  • symptomatic patients with chronic stable angina at intermediate risk of coronary artery disease (CAD), or
  • symptomatic patients with unstable angina at a low risk of short-term death and intermediate risk of CAD.
CMS has now left the recommended trial in the hands of the industry.

“This is typical of governmental policy changes, where there is no clear evidence who is going to pay for the trial,” said Michael Poon, MD, an associate professor of medicine at Mount Sinai Medical Center in New York City and president of the Society of Cardiovascular Computed Tomography (SCCT).

It is often the case that with restrictive research protocols academic institutions are the only facilities capable of funding and maintaining such research. The losers are smaller, rural hospitals and clinics that could not afford to conduct randomized control studies and, therefore, could not offer their Medicare patients the benefit of CCTA, Poon told Cardiovascular Business News.

Instead of the proposed national coverage decision, the societies want CMS to continue to allow local Medicare carriers to determine coverage through the local coverage determinations process. Because all 50 states and Washington, D.C., currently permit access to CCTA for many Medicare beneficiaries undergoing evaluation for coronary artery disease, the societies believe the local agencies are better equipped to evaluate access to the diagnostic tool.

The national coverage decision will supersede the local coverage determinations, which have been established nationally for the past few years.

“Normally, going from local to national is a good sign because it indicates the entire country is willing to undertake the same standards, has confidence in a technology, and CMS is willing to pay for it. But this time, the national coverage decision has an additional aspect called coverage with evidence development,” Poon said.

Medicare’s actions are unprecedented because more than 90 percent of healthcare is done at the local level. Very few procedures are given national coverage, he said.

“If everything physicians did required coverage with evidence development, we’d all stop practicing medicine and start flipping burgers. The majority of what we do in practice has no randomized control study to support the procedures, including surgery,” Poon said.

Poon is not alone.

 “I believe that CMS wants to do what is best for their beneficiaries. However, I also believe that its analysis of CCTA was premature. I don’t think the government yet appreciates the advances in the field that could lead to improvement in diagnosis and cost savings that will ensue if the test is utilized and reimbursed properly,” said Kim Allan Williams, MD, director of nuclear cardiology at the University of Chicago.

Unfortunately, private payors generally adopt CMS proposals, especially when they perceive that it might result in cost-savings for them, Williams said.

According to the published statement, six reasons exist why CMS not adopt the proposed policy change:
  • CMS did not conduct an adequate, thorough analysis of all available relevant evidence. It excluded from review about 75 percent of the available literature supporting CCTA utilizing 64-slice CT scanners.
  • CMS only referenced one out of four multi-society studies that evaluate the appropriateness of CCTA.
  • CMS ignored several well-established applications of CCTA including for coronary artery anomalies, to clear up prior equivocal test results, to assess bypass graft location, and coronary artery evaluation prior to noncardiac surgery.
  • Several definitions of patient populations by CMS conflict with those established by the 2007 ACC/AHA guidelines.
  • The questions that CMS outlined for clinical studies to qualify for coverage with evidence development are inappropriately defined and are unlikely to yield beneficial information.
  • Finally, local coverage determinations have 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 say that the proposed national coverage decision will only slow the development of evidence by academia, societies and registries rather than accelerate it.
The statement was jointly submitted by the American College of Cardiology, American College of Radiology, American Society of Nuclear Cardiology, North American Society of Cardiovascular Imaging, Society for Cardiovascular Angiography and Interventions, and the Society of Cardiovascular Computed Tomography.

The statement 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.

It highlighted the work done to develop appropriateness criteria, credentialing guidelines, and data registries.

Poon said that the proposed change cannot be motivated by fiscal concerns, because it will only increase costs dramatically.

“Right now, we use CCTA as a gate-keeper before a patient goes to the cardiac catherization lab, which is significantly more expensive and riskier than CCTA,” Poon said.

He also criticized the timing of the announcement of the proposed changes, Dec. 13, right around all the holidays.

The joint statement was sent 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.

To view the multi-society letter, click here: