Baltimore, MD - The Centers for Medicare and Medicaid Services (CMS) has announced that Medicare can reimburse for the microvolt T-wave alternans (TWA) test, which is used to help risk-stratify candidates for primary-prevention implantable cardioverter defibrillators (ICDs) [1]. But it declined to allow coverage of external counterpulsation (ECP) therapy for heart failure or Canadian Cardiovascular Society (CCS) class 2 angina, which would otherwise have been added to the currently covered indication of severe angina not amenable to revascularization [2].

As chronicled by heartwire, the CMS has long viewed the electrocardiography-like TWA test as a potential addition to its currently broad reimbursement-eligibility criteria for prophylactic ICDs. According to the agency's decision memo, the test "is a useful risk-stratification tool and can identify which heart patients are at negligible risk of sudden death and who may therefore be able to avoid ICD implantation and its attendant risks." It monitors for beat-to-beat microvolt-level variations in the shape of the T wave during exercise stress that have been consistently prognostic in a number of studies.

But Medicare will also allow other risk-stratification criteria, such as LVEF and the signal-averaged ECG, and not actually require that TWA be included, according to the decision memo.

The CMS decision is a likely lift for the test's leading manufacturer, Cambridge Heart (Bedford, MA), whose proprietary "spectral-analysis" algorithm for measuring TWA was stipulated as the only one allowed under Medicare. The company's device and algorithm have been on the market since 2002, and it is covered by many other third-party payers across the US.

The agency considered allowing a competing analysis method called modified moving average (MMA) but was impressed by the "numerous trials that enrolled adequate numbers of human subjects and used patient-relevant clinical outcome end points" supporting the Cambridge Heart method. "The evidence base for the MMA method is smaller and, though suggestive of benefit, is not yet convincing."

Cambridge Heart's CEO David A Chazanovitz was understandably upbeat in a company press release. Calling special attention to the spectral-analysis-algorithm requirement, he said, "The decision represents the clinical validation of microvolt TWA testing and . . . will serve as a catalyst for clinical cardiologists to refer to implanting physicians those patients most likely to benefit from ICD therapy."

In their quest to earn more respect for the controversial ECP, the two highest-profile manufacturers of the equipment—Vasomedical (Westbury, NY) and Cardiomedics (Irvine, CA)—had separately asked the CMS to expand coverage to a number of new indications. Their requests collectively encompassed CCS class 2 angina, stable NYHA class 2-3 HF with an ejection fraction <40%, any NYHA class 4 HF, acute HF, cardiogenic shock, and acute MI. The agency rejected all of them. "The accumulated data do support the current usage in those who are not amenable to surgical intervention but do not support the expansion of coverage," the decision memo states. All of the indications, however, fall under the technology's labeling by the US Food and Drug Administration.

As recently reported by heartwire, the Blue Cross and Blue Shield Association network of companies declined for similar reasons to support reimbursement for ECP for any indication. But at least some of the coverage plans under its umbrella, which encompass virtually the entire US and make such decisions individually, are reimbursing for some uses.

The Cardiomedics website appears to lack a response to the CMS decision, but Vasomedical has posted and circulated a statement from CEO Thomas Glover that refers to the technology by its own proprietary name, enhanced external counterpulsation therapy (EECP). "We believe the breadth and quality of clinical evidence supporting the use of EECP therapy in patients with congestive heart failure, including the most recent results from the PEECH trial, especially in patients aged 65 and older, clearly demonstrates the significant benefits obtained by patients, including improvements in the ability to exercise, a reduction in symptoms, and an improved quality of life."

In January 2006, the company gave the CMS subgroup data from the trial mentioned by Glover, the Prospective Evaluation of EECP in Congestive Heart Failure (PEECH), which had been presented at the American College of Cardiology 2005 Scientific Sessions. The results were mixed, although the technology improved exercise tolerance and NYHA class. In its decision memo, however, the agency said it could have given more weight to the PEECH results had the trial actually been published.

Citing no control over publication schedules, Glover said in the statement, "We will continue to work closely with the CMS to determine what actions will be required once the trial results are published."