Reversing a proposed decision issued in December, the federal government said Wednesday it would continue to cover the use of an increasingly popular procedure to detect heart disease.
The Centers for Medicare and Medicaid Services said it would continue to cover the scanning procedure, despite its earlier misgivings over whether there was enough evidence to justify paying for the tests under Medicare.
The agency said Wednesday that it would continue to leave payments for the scans up to the local insurance carriers it employs to oversee medical claims. Most local carriers have been covering the test, a form of CT scan that can cost $600 or more.
“We found that the evidence is not black and white either way,” said Dr. Barry Straube, chief medical officer for the Centers for Medicare and Medicaid Services. Given the overwhelming criticism of the preliminary decision, the agency decided it did not have enough reason to override local carriers’ decision to cover the tests as medically necessary.
“Before we make a significant change in policy, we need more evidence,” said Dr. Straube, who indicated the agency would still like studies testing whether the scans are medically effective.
But much of medicine, including treatments Medicare pays for, is similarly unproven. “There are a lot of technologies, services and treatments that have not been unequivocally shown to improve health outcomes in a definitive manner,” Dr. Straube said.
Medicare paid for roughly 70,000 of the heart scans in 2006, according to the agency, at a cost of $40 million to $50 million. For people not yet eligible for Medicare, thousands of other such scans were paid for by commercial insurers or from patients’ own pockets, at prices sometimes close to $1,000. As many as 1,500 centers around the country are estimated to be offering the scans, with some centers advertising their services.
The agency’s decision to continue paying for scans means their use is likely to continue to climb, according to doctors and insurers. Private insurers often follow Medicare’s lead on what medical procedures they will pay for.
The scans are now widely promoted as a noninvasive alternative to tests like angiography, which requires the insertion of a catheter into the blood vessels and can cost thousands of dollars. But conventional angiography is typically done only on patients with cardiac symptoms. There is growing concern that the CT scans are being done increasingly on those who show no signs of heart disease, subjecting them needlessly to radiation risks.
“Before it enters widespread use, it needs to be critically examined, and it has not been,” said Dr. Mark Grant, a senior scientist for the Blue Cross and Blue Shield Association, which told the agency it favored further study.
In December, the Centers for Medicare and Medicaid Services had said it would not pay for the scans unless patients were enrolled in a study to test the technology’s effectiveness. The Blue Cross group said Wednesday that without a Medicare mandate for such research, there might be little likelihood now that doctors or equipment makers would do it.
The proposal to curtail payments met with fierce resistance from doctors who perform these scans and companies that make the equipment. They strongly defended the scans as an important alternative to conventional angiography and said patients who could not enroll in a study of the scans would be unfairly denied access to the technology.
“I think this is great news for patients,” Dr. Constantino S. Peña, the director of vascular imaging at the Baptist Cardiac and Vascular Institute in Miami, said of Wednesday’s ruling.
Among the organizations advocating Medicare coverage were professional societies representing doctors who do scans, including the American College of Cardiology and the North American Society for Cardiac Imaging.
“The biggest role we played is educating” the Medicare agency, said Dr. Pamela K. Woodard, the society’s president.
Proponents argue that many studies are being done. “Within one year, there will be 10 times as much evidence of the effectiveness” of the heart scans, said Dr. Daniel S. Berman, president-elect of the Society of Cardiovascular Computed Tomography, who said his group and others presented the agency significant evidence of the scans’ usefulness.
But the Centers for Medicare and Medicaid Services, in the final decision, said there remained “uncertainty regarding any potential health benefits” from the scans and described the existing evidence as of “overall limited quality and limited applicability.”
Given the amount of resistance, the agency was not able to justify scaling back coverage, said Dr. Sean Tunis, a former Medicare official who is director of a nonprofit group, the Center for Medical Technology Policy, aimed at evaluating new technology. “Without new evidence that something is either ineffective or harmful,” he said, “it’s very hard for Medicare to narrow existing coverage.”
And yet, Dr. Tunis said, Wednesday’s decision indicates the agency “continues to feel there are important unanswered questions.” His group had been in discussions with health insurers and equipment makers to consider conducting the studies that the agency originally envisioned, as a way to show whether the technology was, in fact, better than existing tests and improved patients’ health.
Without the Medicare agency’s insisting upon them, such studies would probably now be more difficult to organize, he acknowledged, although he said he planned to reach out to members of the working group to determine what steps might be taken.
