Medical Device Daily Washington Editor

Stroke is still one of the deadliest and most debilitating diseases, and treatments for one of the primary sources of strokes, intracranial atherosclerotic disease (ICAD), are few and far between.

The Centers for Medicare & Medicaid Services, however, shows it is in no hurry to reimburse for angioplasty and the use of stents to treat stenosis of intracranial arteries for patients who have shown no improvement via medical management.

CMS undertook the review of this indication last year at the behest of Boston Scientific (Natick, Massachusetts), which earned a humanitarian device exemption from FDA in 2005 for the Wingspan stent, used along with the company's Gateway balloon catheter in treatment of ICAD. The threshold of closure of arteries in Boston Sci's request was for arteries 50% or more closed.

CMS opted in November 2006 to reimburse for ICAD in clinical trials, but the agency's Feb. 14 proposed decision memo states that some of the arguments in favor of full coverage are based on trial data that set the threshold for intervention at 70% closure of the target vessel. CMS also states in the memo that one commenter acknowledged "too few patients to create a strong evidence base for stenting superiority compared to medical therapy," That commentator nonetheless urged CMS coverage expansion, "especially for those who are experiencing multiple transient ischemic attacks on Coumadin (warfarin) and Plavix (clopidogrel)."

CMS said that data from a trial dubbed the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) might clarify the picture, but the agency has to close out its decision before by May 14, before that data are available.

The memo says that much of the data is from case studies, rather than randomized trials and that one set of registry data indicates an in–stent restenosis rate of 29.7%.

CMS concluded: "Given the invasive nature of this treatment and the severe risks ... a well–conducted, randomized controlled trial is needed," an argument it said was supported by several journal articles published last year.

The memo says that while CMS "believes the evidence is promising," the agency nonetheless wants to see data from SAMMPRIS before expanding coverage. CMS also states that "the coverage with study participation (CSP) form of Coverage with Evidence Development is applicable only for items and services where the medical evidence is not adequate for coverage," and since Medicare already pays for CSP participation, further coverage is not indicated.

One of the commentators on the issue, the Society of Interventional Radiology (SIR; Fairfax, Virginia), has supported reimbursement with a letter arguing that angioplasty/stenting in this area offers "significant reduction in the annual stroke rate for these patients when compared to any form of therapy, particularly medical therapy."

In the letter, David Sacks, SIR president, said data from the Wafarin v. Aspirin Symptomatic Intracranial Disease (WASID) study "show the lack of effectiveness of any form of medical therapy in preventing recurrent stroke," and that patients with 70%–90% occlusions experience stroke and death at a rate up to 23%.

The letter also states that inasmuch as the diagnostic and treatment procedures related to the condition are bundled, the association would like CMS to clarify "how providers are to garner appropriate reimbursement for the inclusive catheterization and diagnostic angiography components (that would typically be considered covered services) of these currently non–covered intracranial services."

Dawn Hopkins, director of reimbursement for SIR, emphasized SIR's disappointment in the bundling of diagnostic and treatment for ICAD, but she told Medical Device Daily that she did not see much chance of reversing the agency's current stand. "Until there's some new literature, I don't think there's much chance of change," she said.

As to whether the SAMMPRIS trial might encounter difficulties due to the reluctance of some patients to be randomized to standard medical therapy, she said, "Certainly. I think everyone faces that across the board."

At press time, Boston Scientific had not returned calls for comment.

'07 a device lobbying record year

Medicare is a huge player in the device reimbursement arena, so device makers well know the importance of a presence on Capitol Hill. New statistics compiled from a website that tracks lobbying expenses show just how keenly device makers and medical suppliers appreciate getting their messages delivered to Congress.

An article appearing recently at twincities.com says that medical supply companies and device makers coughed up better than $28 million for lobbying activities in 2007, a rise of roughly $2 million over the previous year.

Not surprisingly Medtronic (Minneapolis) was one of the leaders at $1.7 million, exceeded only by Boston Scientific (Natick, Massachusetts) at $1.96 million.

St. Jude Medical (St. Paul), another big Minnesota–based cardiovascular player, had a lobbying war chest of only $460,000, according to data provided by the Center for Responsive Politics (CRP; Washington), which operates the opensecrets.org website, which tracks lobbying expenses and campaign finance donations.

However, anyone worried about the device industry overwhelming Capitol Hill with lobbyists should take comfort in knowing that the pharmaceutical industry has a large lobbying lead. Pharmas led all comers in 2007 with almost $220 million spent on lobbying.

The device industry's $28 million lobbying tab would not make even the top 20 list. The lowest figure on the top 20 list was spent by the commercial banking industry, somewhat more than $45 million.