The government has reversed its decision not to reimburse for PET as a primary diagnostic study assessing myocardial viability. The shift followed lobbying by nuclear medicine advocates and further review of the evidence.
The Centers for Medicare and Medicaid Services had previously ruled that PET would be covered only after an inconclusive thallium-201 SPECT exam. But on Feb. 20, it announced that either FDG-PET or SPECT may be used as the initial diagnostic tool to determine myocardial viability prior to revascularization.
The ruling further states that PET following an inconclusive SPECT remains covered, but SPECT following an indeterminate PET is not. Because of PET's greater specificity, SPECT has no added value in those cases, according to CMS.
"It's never been a scientific question, only a reimbursement question," said Dr. Robert Henkin, acting chair of radiology at Loyola University in Maywood, IL. "We've been doing these studies for years, just not getting paid for Medicare patients."
Last October, the American College of Cardiology and the American Society of Nuclear Cardiology appealed to CMS to reconsider its original thumbs down. They wrote that FDG-PET is widely accepted as the gold standard for myocardial viability. The two organizations relayed results of 26 studies since 1995 that supported the superiority of PET as a functional imaging method for the detection of viable myocardial tissue.
CMS also evaluated three other technology assessments that offered the following conclusions:
- PET is comparable or superior to other myocardial perfusion imaging alternatives
- PET had a higher specificity and was a better predictor of myocardial recovery than SPECT
- PET can help predict postrevascularization outcomes
CMS also considered the FDA's determination that FDG can be safe and effective in patients with coronary artery disease and left ventricular dysfunction. In addition, the Agency for Healthcare Research and Quality concluded that the only reason to prefer SPECT would be based on the availability of PET scanners.
The number of cases in which this test is used -- patients with hibernating myocardium or potential transplant recipients -- is small, according to Henkin. He averages about one patient a month and will probably double that number under the new policy.
"CMS understood they weren't opening the doors to an avalanche of patients," he said. "It's an important but narrow indication, another niche in the expanding PET coverage."
On Dec. 15, 2000, when CMS (then HCFA) made the original decision to cover PET for myocardial viability following an inconclusive SPECT exam, it also approved broader PET coverage for all oncological indications and for refractory seizures (presurgical evaluation only). When this decision took effect the following July, CMS announced it was limiting that coverage to full-ring dedicated scanners.
Just last month, CMS decided against reimbursing for FDG-PET in diagnosing Alzheimer's disease. A decision is pending whether or not to cover PET for recurrent breast cancer.
-- By C.P. Kaiser
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