For InSightec, CMS Holds Ticket To Treating Fibroids In Younger Women
From the March 19, 2007, issue of "The Gray Sheet"
The lack of third-party reimbursement has hindered sales of InSightec's ExAblate 2000 uterine fibroid treatment, but the firm is hopeful that recent recommendations from CMS' advisory panel for hospital outpatient payments will help the unique treatment gain traction.
"The CMS payment level is really critical to providing access to this technology, and it's really what is holding back widespread adoption," InSightec Director of Marketing Lynn Golumbic told "The Gray Sheet."
At its March 7-8 meeting in Baltimore, the APC (ambulatory payment classification) advisory panel agreed that ExAblate 2000 fits best in the outpatient APC for Level III stereotactic radiosurgery, which pays $3,896 in 2007. The panel agreed that ExAblate's image-guided component sets it apart from other, minimally invasive uterine fibroid treatments.
CMS will take the APC panel's recommendation into account as it prepares its proposed 2008 outpatient payments, expected to be released in August.
ExAblate 2000 is the only FDA-approved magnetic resonance-guided focused ultrasound (MRgFUS) device.
FDA approved ExAblate 2000 in 2004, but only about 20 systems have been installed in the United States, in large part because the current Medicare payment for the non-invasive procedure is less than the cost of performing it, Golumbic says.
Based on analysis of data from five hospitals, InSightec says it costs between $7,050 and $8,600 to treat a patient with ExAblate 2000.
InSightec had requested that the APC panel recommend payment of $8,250. However, including codes for preparation and follow-up, total payments for the ExAblate procedure under the radiosurgery APC would total around $8,000, according to Golumbic.
This year, Medicare hospital outpatient payments for the ExAblate 2000 procedure map to two APCs for female reproductive procedures with payment rates of $1,752 and $2,642, about the same as minimally invasive uterine fibroid treatments.
Boston Scientific's Contour and BioSphere Medical's Embosphere uterine fibroid embolization procedures can be coded under the APC paying $2,642 in 2007. Cytyc's NovaSure and Johnson & Johnson/Gynecare's Thermachoice endometrial ablation procedures can be coded under an APC paying $2,091.
Uterine fibroids usually afflict women too young to be Medicare-eligible, but private payors closely link their outpatient payment levels to CMS' rates, Golumbic explained.
No major private payor routinely covers ExAblate 2000, but some payors will pay for the procedure on a case-by-case basis, according to Golumbic. Many payors say they are waiting for data to be published from the FDA-mandated three-year postapproval study. "It's going to be critical information," she said.
Three-year follow-up has been completed for the 109 patients that participated in the device's FDA pivotal trial. Of the 160 patients in the postapproval study, not all have reached two-year follow-up, and a cohort of 73 African American patients is at about six-month follow-up, according to Golumbic.
A 2005 assessment from BlueCross BlueShield's Technology Evaluation Center concluded that available data on MRgFUS - especially data on the procedure's durability - were not sufficient to demonstrate a net health benefit from the treatment.
Meanwhile, InSightec is moving ahead with clinical trials for cancer applications for the device. The firm hopes to begin a pivotal trial within the next few months to support FDA approval of ExAblate 2000 for pain palliation in patients with bone metastases who fail radiation treatment, Golumbic said.
Other indications being investigated, including breast cancer and brain tumors, will take much longer for InSightec to commercialize and require longer trials, she noted.
The Israel-based firm is backed by GE Healthcare, which holds a 20% stake. Israeli firm Elbit Medical Imaging, which co-founded InSightec with GE Healthcare in 1999, and MediTech Advisors are also shareholders.
- Chloe Taft
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