Medical Device Daily Washington Editor

WASHINGTON – Coverage decisions handed down by the Center for Medicare and Medicaid Services (CMS) can spell good news or disappointment for device makers, many of which depend on Medicare reimbursement to maintain sales.

Cambridge Heart (Bedford, Massachusetts) was the recipient of favorable news when CMS recently delivered a determination in favor of the company's cardiac sensor device, dubbed the HearTwave II System, to detect low-level heartbeat variations on the order of a millionth of a volt. During a March 22 conference call discussing the decision, Cambridge President and CEO David Chazanovitz celebrated the decision as a “very satisfying result in a year-long process of evaluating the evidence.“

According to the company's web site, the device's sensors can detect subtle variations in heartbeat, known as microvolt T-wave alternans, “even in the presence of the noise typically encountered during exercise stress testing“ and allow clinicians to record “up to four ECG signals from the same anatomical site.“

The test is designed to establish whether any patient at risk of sudden cardiac death is a good candidate for an implanted cardioverter defibrillator (ICD).

Much of the drive behind CMS's interest in this technology comes from clinical study data that suggest that only about one in five ICDs routinely restore the patient's heart rhythm, making the $4 billion spent on ICDs in 2005 an expensive fix. The realization that a “large proportion of patients who receive an ICD never receive any therapy from their device,“ prompted the agency to seek “additional risk stratification methods.“

Chazanovitz added that this declaration puts control of testing “into the physician's hands, and this is exactly what we asked for.“ He was quick to point out also that the CMS decision was contingent on the use of the company's analytical logarithm, described only as the “Spectral Analytical Method.“

CMS did not approve of payment for the device's use with an alternate logarithm, known as the MMA (modified moving average).

Chazanovitz said that this was because the clinical data generated in support of the sensors is based on the use of Cambridge's algorithm and the associated interpretation criteria and a CMS review of the literature failed to disclose any large-scale studies employing the MMA – hence, the exclusion.

Another winner in the CMS derby is For Patients (Chapel Hill, North Carolina), maker of the CathSling, a decidedly low-tech product designed to support central venous catheters. The patent-pending cloth-and-Velcro sling was invented by the company's founder, Carol Walborn, who came up with the idea while undergoing chemotherapy treatment.

The CathSling, which the firm had to run through the FDA gauntlet, is cleared for distribution to patients who will endure sustained – sometimes 24/7 – use of Hickman-type catheters during extended treatments. Typically, the catheters are fastened with tape and may be subject to tugging and pulling, which can dislodge a catheter and expose the patient to infections at a time when their immune systems may be profoundly compromised. The firm's offering comes in a pouch with two slings, sterile wipes, alcohol swabs, latex-free gloves, and Tegaderm dressing.

A company not faring so well with CMS is Vasomedical (Westbury, New York), whose principal product is the enhanced external counterpulsation (EECP) system. CMS opted to maintain the reimbursement status quo for the company's EECP equipment, which is covered for Canadian Cardiovascular Society Classification (CCSC) III or IV refractory angina in patients whose conditions cannot be addressed by surgical intervention due to inoperability, high-risk co-morbidities or coronary anatomy features that are not amenable to revascularization.

The therapy entails pneumatic cuffs affixed to the patient's legs for rapid inflation and deflation timed to coincide with the heartbeat. Vasomedical states that this amplified blood flow increases “oxygen supply to the heart while lowering its need for oxygen.“

The agency reviewed the use of EECP for CCSC II angina and several other conditions, including cardiogenic shock, acute heart failure and acute myocardial infarction, and concluded that the data did not support a conclusion of reasonability and necessity. The review also included use of EECP for New York Heart Association (NYHA) Class II and III stable heart failure symptoms with an ejection fraction of less than or equal to 35% and less than or equal to 40%.

In a March 21 statement, Vasomedical's president and CEO Thomas Glover admitted to being “disappointed by the CMS decision,“ which he said may have hinged on the fact that the results of the PEECH (Prospective Evaluation of EEECP in Congestive Heart Failure) trial have not made their way into peer-review publication. Glover said that he had expected the results would have been published in time for CMS review “based on historical publication time frames,“ but promised to continue “to work closely with CMS to determine what actions will be required“ once study results find their way into print.

In a March 10 press release, Vasomedical sought to clarify the results of an analysis of EECP therapy by the Blue Cross Blue Shield Association . Glover stated that recent news coverage may have led the public to erroneously conclude that the insurer's plans “do not or will not provide reimbursement coverage,“ but insisted that “the majority of the independent Blue Cross Blue Shield plans have completed their own analyses . . . and [intend to] maintain coverage for their members.“

Among the plans said to have opted to continue coverage were plans operating in Pennsylvania, Florida, California, New York and several others. Glover indicated that other plans would “consider reimbursement coverage on a case-by-case basis.“