Medical Device Daily Washington Editor

With the Medicare crunch just around the actuarial corner, two members of the Senate have offered a bill that would create a public-private partnership for comparative effectiveness research, giving a bit more daylight to a proposal that has made the rounds in the nation's capital for several years.

However, there are two problems with the bill. The new entity would steal much of the mission of the Agency for Healthcare Research and Quality, and some question the level of funding for the entity, which is pegged at $5 million the first year. However, the short time left in the current legislative cycle strongly suggests that this is designed more to lay out a framework for such discussions in the 111th Congress than to pass as a bill this year.

Titled the "Comparative Effectiveness Research Act of 2008," the bill – which is sponsored by Senate Finance Committee chairman Max Baucus (D-Montana) and Senate Budget Committee chairman Kent Conrad (D-North Dakota) – would set up a trust fund financed by the taxpayer to the tune of $5 million in fiscal 2009, a sum that would quintuple the following year, and triple again in 2011 to $75 million a year for each year through fiscal 2018. Any further funding would come at least partly from insurers, whom the bill would require to provide half a dollar for each person covered in fiscal 2012, a fee that would double in the following years. This additional revenue stream is said to offer funding of as much as $300 million a year by 2012.

Stephen Ubl, president of the Advanced Medical Technology Association (AdvaMed; Washington) said in a statement that while the association "is committed to the principles of evidence-based medicine," the association's members are of the view that "research should focus on comparative clinical effectiveness, and not on cost-effectiveness." Ubl also remarked, "it is also essential that research recognize the unique iterative nature of device innovation when establishing research priorities and conducting studies."

David Merritt, healthcare projects director at the Center for Healthcare Transformation (CHT; Washington) told Medical Device Daily, "conceptually, the bill is exactly where we need to go." However, he said, "what jumped out at me ... is the bill's paltry level of funding," which he described as "not even a drop in the bucket compared to what's needed." Given the annual NIH budget of $30 billion, "it makes absolutely no sense from a budgetary standpoint," he said.

When asked if the short timeline in the remaining legislative cycle meant that the bill is aimed at 111th Congress, which takes over in January, Merritt said, "that's absolutely right." He said he sees no passage of any bills of consequence at this point for the 110th Congress, but S. 3408 "certainly will set up the debate next year."

CMS declines more coverage for CAS

CMS has decided to hold its ground on its current reimbursement for angioplasty and stenting for carotid artery occlusion, which is widely seen as the primary driver of stroke.

According to CMS, between "20% and 45% of all strokes in patients with 70%-99% carotid stenosis are unrelated to the carotid disease," and "aggressive medical therapy would be the most important treatment" for those whose strokes are not due to carotid artery disease "since surgical intervention would not reduce these strokes."

The current coverage set-point for carotid artery stenting (CAS) is for symptomatic patients who exhibit 70% occlusion, but a coalition that includes the American College of Cardiology (ACC; Washington), requested that the agency expand the reimbursement set-point to include patients with symptomatic carotid artery stenosis of 50% or greater or asymptomatic carotid artery stenosis of more than 80%.

However, some clinicians, including Peter Bell, MD, of the Royal Infirmary Hospital (Leicester, UK) see the procedure as overused (MDD, Nov. 20, 2007). Bell was quoted in MDD as stating "the majority of those using [carotid artery stents] cause more problems than are caused by endarterectomy."

CMS took the position in the July 31 memo that for CAS to be necessary and reasonable for the asymptomatic patient whose stenosis is greater than 80%, "the perioperative morbidity and mortality rates should be less than 3%." The agency set a limit of less than 6% death and stroke within 30 days of the procedure for patients with stenosis less than 50%. CMS said the literature "does not demonstrate that CAS can be performed at that level."

Levitronix recalls blood pump

Levitronix (Waltham, Massachusetts) reported a recall of its CentriMag extracorporeal blood pump system made in its plant in Zurich, Switzerland due to an interaction with electrosurgery devices. According to the recall notice, physicians have been informed that use of the CentriMag in conjunction with the Force FX-C or SSE2L electrosurgery devices, made by Valleylab (Boulder, Colorado), "may result in stoppage of the pump and may cause serious injury or death." Levitronix indicated that the recall "is an interim fix while the firm further investigates the source of the problem."