Acuson given pass-through status for catheter

The Health Care Financing Administration has granted Acuson’s AcuNav diagnostic ultrasound catheter pass-through Medicare reimbursement status for outpatient procedures, paving the way for its introduction into the electrophysiology market.

The assignment, effective Aug. 1, was made under HCFA’s Medicare and Medicaid prospective payment system. It enables outpatient centers, usually cardiac catheterization or electrophysiology labs that are under the control of hospitals, to receive reimbursement for the product based on the amount of money that individual hospitals charge for procedures using the device. Inpatient procedures are reimbursed under a different system.

The pass-through code applies only to Acuson’s AcuNav and not to intravascular or intracardiac diagnostic ultrasound devices in general, said Judy Bartlett-Roberto, senior marketing manager for Acuson’s interventional devices organization. However, other companies have received similar consideration. Scimed Systems, a division of Boston Scientific, earlier received pass-through assignment for its UltraCross coronary imaging catheter, said Rosemary Brekke, director of reimbursement and outcomes planning for Scimed.

“What’s exciting about this is it’s allowing us to sell to an entirely new market—electrophysiology—where we don’t really have an installed base,” Bartlett-Roberto said. “The potential upside for us is enormous.”

Traditionally, outpatient services covered by Medicare have been reimbursed on a reasonable-cost basis. However, under congressional mandate a prospective payment system based on 1996 data was developed in 1998. Because the system was not scheduled to go into effect until 2000, the pass-through provision was established to avoid using older data to determine payment, said Stuart Langbein, a regulatory consultant for Acuson.

“Congress stepped in and said that a means of making sure that new technologies are paid for appropriately was needed,” said Langbein, an attorney with Washington, DC-based Hogan and Hartson.

Over the years, Scimed and Endosonics have been the overwhelming market leaders for the development and sale of intravascular and intracardiac ultrasound devices. However, Acuson hopes the new reimbursement assignment will enable the company to substantially increase its market share.

“We’ve always stated publicly that we expect AcuNav to be contributing between $30 million and $50 million in revenue to Acuson over the next three to five years,” Bartlett-Roberto said. “The assignment of the pass-through code increases our confidence that we’ll be able to meet those numbers.”

The AcuNav catheter, which is inserted through the femoral or jugular veins, has many diagnostic uses. Designed to capture high-resolution ultrasound images of the entire heart from the inside out, it can steer 160º in all directions and switch from 2-D gray-scale imaging to highly sensitive and precise Doppler modes. Cardiologists who use the device are able to obtain information about cardiac structures and functions; the great vessels; blood flow quantity, direction, and velocity; regional myocardial tissue motion; and diagnostic or therapeutic devices that are in the heart—including pacemaker leads or ablation catheters.

Acuson’s focus during the coming years will be on the estimated 600 electrophysiology labs that are in operation in the U.S. The company already has some 18,000 systems in place worldwide, many of them capable of using AcuNav, Bartlett-Roberto said.

Repeated efforts to contact an Endosonics representative for comment were unsuccessful.