The Centers for Medicare & Medicaid have been especially busy in the cardiovascular sector the past few weeks, resisting coverage, or added coverage, in some areas, approving broader coverage in at least one sector.

CMS indicated it is in no hurry to reimburse treatments for one of the primary sources of strokes, intracranial atherosclerotic disease (ICAD), and will not 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 review of this indication last year in response to a request by 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 Scientific's request was for arteries 50% or more closed.

CMS issued a ruling in late 2006 to reimburse for ICAD in clinical trials, but the agency's proposed decision memo, issued this past February, 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 commentater 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 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.

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

In an SIR letter, David Sacks, society 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 states that since diagnostic and treatment procedures related to the condition are bundled, the association seeks CMS clarification concerning "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, and she told Cardiovascular Devices & Drugs 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."

No to covering MTWA with MMA

Cardiologists trying to assess a patient's vulnerability to sudden cardiac death have a limited number of ways to predict which patient will actually have such an episode, but increasingly promoted for this is microvolt t-wave alternans (MTWA), which measures ciritical measures of the heartbeat.

However, the currently reimbursed method of measuring the MTWA, known as spectral analysis, is subject to noise and is little help in measuring the MTWA when the patient is active. Hence cardiologists and electrophysiologists are keen on getting CMS to reimburse for MTWA analysis employing modified moving average (MMA), which researchers say yields more relevant data.

Currently, MTWA testing is only CMS-reimbursed when conducted with spectral analysis, and the agency said it will make no change in this policy. It will, however, look at comments "that include new evidence we have not reviewed here."

One of the difficulties in proving the value of MMA is the perception that most incidents of irregular heartbeat occur during other than a resting state, so that an unstressed measurement underestimates a patient's vulnerability.

According to a February proposed decision memo from CMS, the MMA measurement requires that the patient wear a monitor for 24 hours and can be used while the patient is on a treadmill. CMS accepted the petition seeking reimbursement for this testing, filed by GE Healthcare (Waukesha, Wisconsin), last August; it expects to render a decision by May 14.

According to CMS, the first 13 of the public comments weighed heavily against coverage for MMA testing, citing a lack of supporting data. One comment in favor acknowledged the need for randomized trials; another from "the same organization as the entity that requested the reconsideration."

CMS said that "many patients have indeterminate results" from T-wave testing and that the data supporting MMA "is relatively sparse," citing a 2006 study in the British Medical Society's journal Cardiovascular Disorders in 2006.

Prothrombin testing coverage expanded

In mid-March CMS did approve expansion of reimbursement for home testing for prothrombin times. The agency said late last year that it would revisit the question of reimbursement for home-based prothrombin tests in patients taking warfarin, which previously was reimbursed only for patients with mechanical heart valves.

Its decision memo said, "After examining additional evidence, we are expanding Medicare coverage of home prothrombin monitoring to include chronic atrial fibrillation and venous thrombosis."

The agency did attach several conditions, among these is that Medicare will pay for this coverage so long as that the patient has been on anticoagulation therapy for at least three months, "has undergone a face-to-face education program on anticoagulation management" and has demonstrated correct use of the test — this last one of the primary concerns CMS had in approving reimbursement.

The decision memo said that the literature on home self-monitoring has expanded since the 2001 decision for patients on mechanical heart valves, including one study conducted in 2002 that concluded that "no significant differences were found between self-testing and laboratory" tests of prothrombin times.

An assessment conducted in 2005 indicated no significant difference in test results, and backed the notion that patients would use the test appropriately. Patientsalso consistently have backed the idea of conducting the tests themselves.

Kerry Weems, acting CMS administrator, said that beneficiaries "will benefit greatly through the use of the home test."