CMS' expansion of implantable cardioverter defibrillator Medicare coverage incorporates several recommendations from manufacturers and professional societies.

Most important to device stakeholders, the agency has agreed to extend the left-ventricular ejection fraction threshold to 35%, instead of the 30% proposed in the draft memo.

In the Jan. 27 ¹ final national ICD coverage decision memo, the agency states it received 40 stakeholder comments during the public comment period urging CMS to maintain the inclusion criteria of a LVEF <= 35%,="" which="" was="" the="" cut-off="" point="" for="" both="" the="" nih="" and="" medtronic-sponsored="" scd-heft="" and="" guidant's="" companion="">

Both trials showed ICDs were associated with a mortality benefit compared with drug therapy for the total population enrolled in the trials.

CMS observed in its September draft decision that SCD-HeFT showed ICDs are associated with a 23% improvement over standard drug therapy, but showed no apparent benefit associated with ICDs in patients with LVEF 30%-35%. Because no other randomized data were available on ICDs for this sub-group, CMS proposed not to cover it.

However, the SCD-HeFT trial was not powered to measure the benefit in the 30%-35% subset alone, and therefore, commenters argued that the subset analysis did not contradict the total trial population's results.

CMS appears to have been persuaded by stakeholders' arguments. "Since SCD-HeFT included patients with LVEF 30%-35%, coverage will be expanded," CMS states.

In the year since the Medicare Modernization Act began requiring CMS to release proposed decisions for public comment, the agency has rarely made changes between proposed and final coverage decisions.

The decision immediately extends Medicare coverage to patients with LVEF <= 35%,="" non-ischemic="" dilated="" cardiomyopathy="" for="" at="" least="" nine="" months="" and="" new="" york="" heart="" association="" class="" ii="" and="" iii="" heart="" failure.="" the="" agency="" estimates="" that="" 500,000="" new="" patients="" are="" now="" available="" for="" coverage="" annually="">see ² Also see "FDA Commish Pick Imminent? Crawford Finally May Shed Understudy Role" - Medtech Insight, 31 January, 2005.).

Medtronic and the Heart Rhythm Society both praised CMS' coverage expansion in Jan. 27 releases.

CMS also observed that the SCD-HeFT results showed no significant difference in mortality between the ICD and control groups for patients with NYHA Class III heart failure. In the draft memo, CMS proposed to cover Class III patients, but observed: "This finding has been difficult to explain [and] additional consideration of this finding may be forthcoming from the trial investigators."

In a Jan. 27 teleconference announcing the ICD coverage decision, however, CMS Chief Medical Officer Sean Tunis, MD, explained that "we analyzed that [finding] in the context of data from other studies of prophylactic use defibrillators and came to the determination that that was a statistical fluke, and that the overall evidence is that there's a benefit to Class III patients."

Tunis noted that more data on Class III patients will be forthcoming from the ICD database established by the agency in collaboration with a stakeholder working group led by the Heart Rhythm Society (³ Also see "National ICD Registry Proposal Critiqued By Manufacturers, ACC/HRS" - Medtech Insight, 13 December, 2004., p. 5).

To become eligible for an ICD under Medicare, CMS is requiring all recipients be enrolled in the national ICD database, which will be operated by the Iowa Foundation for Medical Care (IFMC).

Stakeholders claimed that providers would not be ready to participate in the registry by the time the decision was implemented. They subsequently asked CMS to suspend the registry requirement until improved computer methods were developed to permit data transfer from the device interrogation programmer to the registry coordinating center.

CMS has attempted to overcome that obstacle by linking the ICD registry to existing data collection operations. "Initially, an ICD database will be maintained using a data submission mechanism that is already in use by Medicare participating hospitals to submit data to the IFMC - a Quality Improvement Organization (QIO) contractor - for determination of reasonable and necessary and quality improvement," the agency explains in the decision memo.

Data collection will be facilitated with an ICD abstraction tool and transmitted via CMS' QNet (Quality Network Exchange) to the IFMC, which will collect and maintain the database, the agency explains. CMS also may certify other ICD registries and trials to supplement or replace the QNet set-up.

Because the ICDs used in SCD-HeFT were single-lead, single-chamber defibrillators programmed for shock therapy without antitachycardia pacing, CMS solicited comments on what, if any, device selection restrictions should be included in the coverage decision.

Most commenters argued that physicians should be free to choose the best device for their patient. Implanting physicians, for example, often add an atrial lead for arrhythmia discrimination and therapy in patients with documented supraventricular tachyarrhythmia.

CMS will allow for physician discretion and "will not limit coverage based on type of defibrillator." However, physicians choosing to implant a device other than a single-lead, shock-only ICD will be required to supply "medical justification of the necessity for a more advanced ICD that potentially has more adverse events. This justification must be based on patient characteristics and evidence from clinical studies and must be documented in writing in the medical records."

"While it is true that the single-lead devices were studied in this analysis and the so-called duals are used more widely in practice today, it's probably not unreasonable to think that the newer [dual-chamber] devices are going to provide a similar kind of benefit," CMS Administrator Mark McClellan, MD/PhD, observed during the conference call.

Nevertheless, CMS "would like to make sure that's the case. That is a hypothesis at this point, and it may turn out that for many patients, the single-lead devices do just as well, and that's additional information we'd like to gather, and that we'd like patients and doctors to have when they're making...clinical decisions on which of these devices is most appropriate."

The final decision memo also adds a provision for NYHA Class IV patients requested by about 20 commenters. CMS excluded these patients from the proposed coverage because they were not studied in the SCD-HeFT or MADIT-II trials. However, the agency ultimately agreed with the commenters that "these patients should be eligible to receive CRT-D therapy with the potential of improving their heart failure Class to III."

CMS Expands ICD Coverage In Long-Awaited Decision; Stakeholders Rejoice

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