So far, the public comment period, which began on June 13, for the national coverage analysis to evaluate the available evidence for coronary computed tomography angiography (coronary CTA) has yielded significant support for reimbursement of the procedure.
CMS said that the gist of the favorable remarks is that, with judicious patient selection, coronary CTA saves money and time and improves patient care. Practitioners best utilize coronary CTA in low- to intermediate-risk patients for its negative predictive value.
Commenters on both sides of the debate expressed concern with radiation exposure and stressed the need for judicious patient selection, proper training and/or credentialing, and continued technological efforts to rein in dose.
Meanwhile, the nation’s most common cardiac malfunction, atrial fibrillation, is challenging regulators to keep up with medical advances, according to an article in The New York Times. The condition afflicts at least 2.2 million people in the United States, according to government estimates. While some experience no symptoms and most others seem to suffer little more than weakness or shortness of breath, the condition is now recognized as a major source of strokes and a precursor to potentially fatal deterioration of the heart.
Now the challenge is soaring payments for treatments and procedures that have yet to be proven effective. Catheter-based ablation is an expensive procedure which proponents say is less invasive than open-heart surgery and more cost-effective than drugs. Federal regulators have not approved any devices used in the procedure, which makes it difficult for providers to be fully reimbursed, to the tune of $25,000 to $50,000.
The FDA plans to schedule a public meeting to discuss treatments for atrial fibrillation in the near future. Major medical societies have endorsed catheter-based treatment even though clinical trials have yet to demonstrate long-term benefits.